Sandoz Sets Ziextenzo Price 37% Below WAC for Reference Neulasta

According to reports, Sandoz has set a price of $3,925 for a 6- mg dose of its new pegfilgrastim biosimilar Ziextenzo™. Based on this pricing, the third biosimilar pegfilgrastim will undercut the wholesale acquisition cost (WAC) of Neulasta® by 37%.

Of course, WAC pricing does not include further discounts or rebates, so we evaluated the average sales price (ASP) (which does) for each of the biosimilar products and reference Neulasta. The Centers for Medicare and Medicaid Services’ latest ASP list (released October 30) was based on data through the second quarter of 2019. This includes Coherus Bioscience’s Udenyca®, as 6 months of sales data were now available to list its initial ASP.

As shown below, Mylan’s Fulphila possessed the lowest ASP pricing, at $3928.92 (calculated as $327.413 for 0.5 mg dose, multiplied by 12 to obtain pricing for equivalent 6-mg doses). The WAC price for Ziextenzo is therefore just below the ASP for Fulphia and 9% below the WAC for both Fulphila and Udenyca.


Product WAC* ASP
Neulasta $6,231 $4,432
Udenyca $4,175 $4,165
Fulphila $4,175 $3,929
Ziextenzo $3,925 N/A
*WAC information for Neulasta, Udenyca, and Fulphila from Prime Therapeutics. ASP information from CMS, calculated based on 6-mg dose.

UnitedHealthcare announced earlier this year that it has decided to cover Amgen’s filgrastim and pegfilgrastim reference products and exclude the biosimilars. Speculation is widespread that this coverage was achieved through a portfolio contracting approach (i.e., even greater discounts and/or rebates were offered by Amgen for covering their short-acting and long-acting agents). Sandoz is now the sole biosimilar source for both filgrastim and pegfilgrastim and could also potentially utilize the portfolio approach.

The real question is whether Sandoz’s entry into the pegfilgrastim market will spur further discounting by Mylan and Coherus, the latter of which recently announced it reached 19% marketshare and hopes to maintain its sales momentum into 2020.

Will Government Action to Spur the Biosimilars Industry Have Any Bite?

“Biosimilars are such an underutilized entity to truly drive down costs and generate savings. We are heartened by the fact that several pieces of legislation have been introduced to help change provider and patient incentives,” said Molly Burich, MS, Director, Public Policy, Biosimilars and Reimbursement at Boehringer Ingelheim.

A panel at last week’s GRx+Biosims meeting focused its remarks on the potential of legislative proposals brewing on Capitol Hill to incentivize biosimilar uptake.

Incentives for Patients and Doctors

In Medicare Part B, Ms. Burich explained, beneficiaries have a 20% co-insurance, and about 85% will have wraparound or gap insurance that covers this out-of-pocket cost. However, about 15% do not. According to Ms. Burich, removing this co-insurance for biosimilar use through the legislative process would generate sufficient savings through the lower costs of these drugs to fund it.

Molly Burich, MS

“Physicians say that patient out-of-pocket costs,” she noted, “are their number 2 concern.” She also raised the potential of utilizing a shared-savings model to incentivize biosimilar use, such as allowing clinicians who prescribe the lower-cost drug to share in the government’s savings. Legislation containing this provision has not yet been introduced, she emphasized.

Another mechanism to induce greater physician prescribing is to increase the average sales price (ASP) add-on payment, where ASP+8% may incent more physicians to prescribe biosimilars. The current payment of ASP+6% hasn’t encouraged sufficient physicians and groups to move to biosimilars, said Ms. Burich.

What About Part D?

Recognizing that virtually all marketed biosimilars are covered under a medical or Part B benefit, Mr. Burich pointed out that “we should be using this time to prepare the Part D benefit for biosimliars.” Many payers currently manage the use of self-administered injectables under the pharmacy (or Part D) benefit, and when adalimumab biosimilars are available in 2023, payers will need to be ready. She said that a couple of ideas were introduced around the Medicare Star ratings for Medicare Advantage plans, by perhaps alerting beneficiaries of lower-cost products being available on formulary.

Erika Satterwhite

As Erika Satterwhite, Head of Global Biosimilars Policy at Mylan, stated, “The core principal of biosimilars is access.” Yet, patent abuse is the number 1 challenge to bringing new biosimilars to the market. Admittedly, after the flurry of discussions earlier this year about the Federal Trade Commission (FTC) exercising its authority to invalidate anticompetitive patents, there is little activity to change this at the moment. Several current proposals in the Congress and Senate attempt to limit the number of patents for biologics that can be claimed subject to infringement (e.g., 20 in at least one proposal), but these bills, if passed, would only affect new biosimilar applications and companies choosing to participate in the “patent dance.”

James Carey

Even some biotechnology manufacturers are beginning to recognize the inherent problems with patents and access. James Carey, Executive Director, US Health Policy, Merck & Co., Inc, said, “Intellectual property [IP] is the lifeblood of our innovation. However, we have made it clear that we have a strong belief that once the IP has been exhausted, safe and effective biosimilars should be available on the market.” One bill in the House would require more transparency around patents; this would be reflected in a far more useful Purple Book than exists today.

Christine Simmons, Executive Vice President of the Association of Accessible Medicines, and President of the Association’s Biosimilar Council, reminded the audience that the inter partes review system “still remains an important avenue to resolve patent disputes.” Yet, as Mr. Carey pointed out, “The courts are clogged with cases—we need more judges to get through the backlog.” Ms. Simmons believes that we must maintain the ability for the biosimilar and innovator manufacturer to settle, and avoid waiting for the full patent expirations (perceived by the reference manufacturer).

What should be the role of the FTC? Ms. Simmons commented that the FTC has long been active on the biosimilars front. “The agency argued that an exclusivity period for biologics was unnecessary, and the FTC argued that the use of four-letter suffixes would harm their uptake. They’ve been engaged around the misinformation as well. However, much of their participation has been rhetorical. They haven’t had the opportunity to dig in,” she said. The panelists would not comment on FTC’s potential role in considering whether rebates were anticompetitive.

Reference Pricing and Drug Pricing

Ms. Satterwhite asserted that the success of biosimilars in Europe was not the result of an external referencing pricing model. “Implementing tenders in a place that does not use them does not get you to lower pricing,” she said.

Reference pricing, Ms. Satterwhite emphasized, could actually reduce access. “The European Commission has recommended against its use on the continent,” she said. “You need to look at the market context of the country you’re focused on.” Ms. Burich added that in the different EU countries, “many incentives were implemented for physicians and patients,” with the objective of  driving awareness of biosimilars.

Biosimilars in the US have long been viewed as a market-based way of increasing competition and lowering drug prices. The proposals today to negotiate Medicare drug prices for up to 250 drugs (as well as use of reference pricing mechanisms) could have a dramatic adverse impact on the pharmaceutical industry—perhaps up to $1.2 trillion over 10 years. “That means jobs will be lost and products won’t make it to market,” said Mr. Carey. He pointed out that Medicare drugs (in the Part B benefit by Medicare Advantage plans and in the Part D benefit by Part D plans) are negotiated heavily today.

Ms. Satterwhite reemphasized that the key point is sustainability of the biosimilar market in the US. “We need to unlock the barriers to sustainable competition, not just seek a short-term price cut.”

The question remains whether the myriad proposals put forth will enable the federal government to have a greater ability to assure this sustainability. To date, there is a great deal of talk but very little substantive action.

In other biosimilar news…Biogen is taking a more active role in promoting biosimilars in the US market. The Massachusetts-based company has been a principal investor in Samsung Bioepis. In 2018, it increased its investment in the South Korean company (to 50%). On November 6, it announced a deal with Samsung Bioepis to be the commercial marketer for SB11, an investigational ranibizumab biosimilar (reference drug, Lucentis®), and SB15, an investigational aflibercept (Eylea®). The new agreement also covers marketing rights for these products in Australia, Canada, Europe, and Japan. Biogen already markets Samsung biosimilars for etanercept, infliximab, and adalimumab biosimilars in Europe.

Partners Teva/Celltrion Seek the Jump on Pfizer, Launch Their Rituximab Biosimilar Next Week

When Pfizer announced its intention just more than a week ago to begin marketing its rituximab biosimilar Ruxience® in January 2020, industry watchers wondered when we might hear a response from its sole approved competitor. The wait was over quickly: Teva and Celltrion will begin shipping their own rituximab biosimilar Truxima® on November 11.

Truxima was approved in October 2018 for the cancer indications of Genentech’s reference product Rituxan®. In a joint press release issued by both companies, Brendan O’Grady, Teva’s Executive Vice President and Head of North America Commercial Operations, stated, “We are excited about the first FDA-approved biosimilar to rituximab in the US. Teva’s commitment to biosimilars is focused on the potential to create lower healthcare costs and increased price competition. This focus is consistent with Teva’s mission of making accessible medications to help improve the lives of patients.”

The press release also mentioned a key detail of the partners’ patent settlement with Genentech. Specifically, Celltrion and Teva will be able to market the autoimmune indications (rheumatoid arthritis, granulomatosis, with polyangiitis, and microscopic polyangiitis) in the second quarter of 2020, assuming they receive approval from the Food and Drug Administration for the broader indications. Ruxience is not currently indicated for these same autoimmune disorders.

The partners announced that the wholesale acquisition cost (WAC) for Truxima will be just 10% below that for Rituxan, which will be subject to further discounts and rebates negotiated with individual payers. That works out to a WAC of $845.55 for 100 mg vial (or $4227.75 for 500 mg vial). Teva will be responsible for marketing Truxima in the US.

Pfizer has not yet announced their intended WAC for Ruxience’s launch in January.

More Positive News From Coherus

On November 6, Coherus Biosciences released information that sent its shares soaring over 17% higher by midday on the 7th. The company announced its third-quarter earnings, which boasted greater marketshare for its lead product as well as a broadened late-stage pipeline.

The company announced that its marketshare for its lead biosimilar product Udenyca® had reached 19% as of end of the third quarter. The company is hoping to crack 20% by the end of 2019. Coherus President Denny Lanfear mentioned on an earnings call that Udenyca share was gained at the expense of both Neulasta® prefilled syringe and On-Body Injector® prescriptions.

In other Coherus news, it disclosed a transaction that provides the company with exclusive rights to an investigational biosimilar version of ranizumab (reference product Lucentis®) from Bioeq. According to Coherus, it has secured exclusive rights to the product’s intellectual property. The big news is that Coherus intends to submit the 351(k) application for this agent before the end of 2019, with a potential launch in 2021. The product purchase likely means the discontinuation of Coherus’ own ranizumab biosimilar (CHS-3351), which was in preclinical development at the time of the acquisition. According to Mr. Lanfear, “This license pulls forward our previously anticipated Lucentis biosimilar launch in the US by about two years.”  

Bioeq will earn an immediate payment from Coherus, and then milestone payments as commercialization advances. Under the agreement, Bioeq and Coherus will both receive a share of the profits postlaunch.

How Did Kaiser Permanente Reach 95%+ Utilization of Biosimilar Herceptin and Avastin so Quickly?

The secret is in the sauce that makes Kaiser Permanente a truly integrated payer, and in its devout avoidance of the Achilles heel of other payers.

At this week’s GRx+Biosims meeting, two sessions with KP’s executives made it startling clear—if you don’t accept rebates, the decision to move to biosimilars is simple.

Amy Gutierrez, PharmD

Amy Gutierrez, PharmD, Senior Vice President and Chief Pharmacy Officer, Kaiser Permanente National Pharmacy Programs and Services, emphasized the organization, especially its California regions (which account for 80% of its membership), is highly integrated. The medical groups and Kaiser pharmacies “strongly collaborate,” coming up with evidence-based reviews of formulary drugs.

At a separate session, Sameer Awsare, MD, Associate Executive Director, The Permanente Medical Group, elaborated, “Our drug information services are critical in doing the evidence-based review.” When an oncology clinician is part of the review, he said, “it’s hard for other oncologists to go against these recommendations. This results in widespread buy-in to the formulary decisions.”

Formulary adherence is about 95%, according to Dr. Gutierrez, and in California, “the plan does not require prior authorizations.”

The Looming Patent Cliff

“Biosimilars are safe, and they have been shown to be as effective as innovator products,” asserted Dr. Awsare. He listed the many reasons why uptake has been slow—pay-for-delay, misinformation, patent litigation, and perverse incentives among the top factors. “Biosimilars have reduced costs because of increasing competition.”

Dr. Gutierrez stated that newer therapies can cost from $500,000 to $2 million. “How can we afford these newer treatments? The abandonment rate for medications that cost patients $250 or more is 69%, and 52% when the out-of-pocket costs are between $125 and $250.” This has significant implications for Kaiser and its 12.3 million members.

With 71 drug patents set to expire through 2023, representing $55 billion in costs, “We hope to take advantage of this with biosimilars,” she said.

Kaiser Permanente’s Biosimilar Journey

The health plan was an early adopter of Zarxio® (filgrastim-sndz). “We learned the ropes with that one,” said Dr. Gutierrez.

Dr. Awsare explained that when Zarxio first came out, the providers questioned the results of the European studies. Kaiser performed a study with its own patients (the first 700 patients to receive the product). “It turned out we saw even less neutropenia than with Neupogen—maybe it’s even a ‘biobetter’,” he stated. The result is that Kaiser Permanente now has 98% uptake on Zarxio, according to Dr. Awsare.

Kaiser decided in 2017 to cover Inflectra (infliximab-dyyb). “At that time, the professional [gastroenterological] societies were inferring this was not the best course of treatment,” said Dr. Gutierrez, and Kaiser Permanente delayed using the biosimilar for the inflammatory bowel disease indications. Kaiser started a registry to ensure that no safety signals were seen after the switch.

When Fulphila (pegfilgrastrim-jmdb) was approved, Kaiser soon decided to cover it in preference to the reference product. And when Amgen launched its biosimilar bevacizumab (Mvasi®) and trastuzumab (Kanjinti®), Kaiser Permanente jumped in with both feet. “The oncology doctors were ready to move to biosimilar trastuzumab and bevacizumab when they were launched,” said Dr. Awsare. “We went to 97% uptake on the Avastin biosimilar in only a month.”

Finally, Ruxience was also rapidly added to the formulary. Kaiser does focus on covering only one biosimilar in a class, to maximize its leverage.

Dr. Gutierrez emphasized that the plan has the ability to get “immediate P&T decisions and put coverage in place rapidly.” This has resulted in biosimilar uptake of 80% to 95%, depending on the product. She explained, we’ve seen greater (and faster) adoption rates with supportive care medications versus direct treatment.”  Overall, the plan has saved about $200 million since we began covering our first biosimilar.”

In cases where a product has a “skinny label,” Kaiser is open to approving off-label indications, if the evidence supports it. “We’re working with our physician groups to gain that evidence,” she said.

Dr. Gutierrez advised that supply and stocking is important. “We might be ready to start using the biosimilar immediately,” she said, “but the manufacturer may not be ready to meet our supply needs. We’re getting better at that.”

“We work to minimize use of evergreening products whenever possible to maximimize the impact of the future biosimilars market,” added Dr. Gutierrez. “We are a leader in US biosimilar use. Manufacturers know that Kaiser Permanente can switch medication coverage fast, and this gives us significant leverage.”

Sandoz Gets FDA Approval for Its Pegfilgrastim Biosimilar, Ziextenzo

Sandoz received its long-awaited nod to begin marketing Ziextenzo, the third pegfilgrastim biosimilar. Approved and marketed in Europe in 2018, pegfilgrastim-bmez should be available for prescription by doctors before the end of 2019, according to Sandoz.

pegfilgrastim biosimilar approved

The FDA approved indications for Ziextenzo include decreasing the incidence of infection (with febrile neutropenia) in patients with non-myeloid malignancies who are administered myelosuppressive chemotherapy.

In the company’s press release, Carol Lynch, President of Sandoz Inc., said, “The approval of Ziextenzo expands our oncology portfolio, providing physicians with a long-acting supportive oncology biosimilar option. It builds on the foundation of trust and experience we developed with our short-acting filgrastim Zarxio®.”

This marks Sandoz’s fourth biosimilar approval, following Zarxio, Erelzi® (etanercept) and Hyrimoz® (adalimumab), and second product to be marketed. Sandoz follows Mylan’s Fulphila® and Coherus Bioscience’s Udenyca® in the pegfilgrastim biosimilar race, which will put greater pressure on Amgen’s reference drug franchise to retain marketshare.

Ziextenzo had a bumpy road to US approval, first submitting a 351(k) application in 2015 and receiving a complete response letter from the FDA in 2016. (Note: all manufacturers of a pegfilgrastim biosimilar have received at least one complete response letter.) Sandoz refiled for approval in April of this year. However, the company now has the opportunity to build upon the success of Zarxio and apply its existing resources to the portfolio of short-acting and long-acting granulocyte-colony stimulating factors.

A Conversation With William Yoon, PharmD, MBA, Head, External Engagement and Medical Advocacy, Sandoz

What is the extent of misinformation on biosimilars and who is most vulnerable to it? We talked with Dr. Yoon about this and a number of related topics.

Biosimilars Review & Report: What do you believe is the greatest challenge (or challenges) today regarding prescriber and patient comfort with using biosimilars as opposed to originator biologics?

William Yoon, PharmD, MBA: Biosimilars face numerous amounts of challenges in the US that have affected patient access to life-changing medicine. First, we have insufficient education. We have learned from our global experience that successful uptake is centered around a multistakeholder approach. It’s critical that we continue to join forces with government, regulators, payers, healthcare providers, and patients to further educate on the value of biosimilars.

William Yoon on biosimilar misinformation
William Yoon, PharmD, MBA

The second major challenge has to be addressing misinformation campaigns. Fortunately, the FDA has recognized there are a number of campaigns that have been initiated by several reference manufacturers; the sole purpose of these campaigns is to spread misinformation. As you know, the FDA is currently working to address this issue.

The third relates to the lack of payment policy incentives to drive biosimilar adoption. The Center for Medicare and Medicaid Services can use several approaches to incentivize biosimilars uptake and savings. We have a team on the Hill who is doing a lot to challenge and knock down the barriers in Part B and Part D. For example, in Medicare Part B, you can have zero dollar co-insurance for patients prescribed biosimilars. On October 1, a bipartisan bill was introduced by Congressmen Peters, King, and Brindisi to eliminate the cost sharing. Another policy incentive could be shared-savings models for physician reimbursement or incentivizing provider reimbursement. In part D, a specialized tier for biosimilars or even the zero-dollar copay like the bill I mentioned could help greatly.

Nonetheless, we all must work together to overcome these barriers and hesitancy to make biosimilars more available. The time for change is right now. We hear a lot about these skyrocketing health care costs. As an organization, Sandoz is committed to biosimilars and ensuring access to these lower-cost options. We were the first to bring a biosimilar to the US and also the first to really have a successful biosimilar story. We have proven biosimilars expand patient access to these life-changing medicines while increasing health care savings and fueling innovation.

BR&R: Let’s delve into the misinformation aspect for a moment. Which groups do you think are most vulnerable to this line of attack? Are patients the only group at risk today, or do physicians still have doubts about biosimilar efficacy and safety?

Yoon: I would say both. Regardless of the source or the communication channel, misinformation around biosimilars is dangerous. It threatens to further forestall the widespread uptake of these valuable medicines. Due to these misinformation campaigns, it’s critical that all stakeholders receive accurate and factual information. The FDA has done a great job providing a Web-based resource for biosimilar education, with videos, fact sheets, infographics, and other materials. They had even developed print ads.

BR&R: To what extent do you think the dissemination of this misinformation on biosimilars sort of mimics what occurred with the initial introduction of generics and generic substitution?

Yoon: Although generic drugs are widely accepted today, there was a significant amount of misinformation in the 1980s about their safety, efficacy, and quality. We’re hearing those same arguments about biosimilars today, in an effort to prevent more people from realizing the potential savings that biosimilars can bring.

Biosimilars approved by the FDA have the same efficacy and safety profile as their reference products. Approved biosimilars have gone through a rigorous development and a testing process. They have the same primary amino-acid sequence,  route of administration, the dosage form, and the strength as their reference product. And they demonstrate matching purity, potency, safety, efficacy and immunogenicity

It’s important to develop and share educational tools that are critical to our stakeholders. I firmly believe that a number of stakeholders play a very critical role in this. Number 1 is patient advocacy groups. They play a major role, because they are highly trustedby both newly diagnosed patients and those living with chronic illness. In today’s information age, enabling patient groups to distribute educational materials is critical. These materials have to be accurate, and they have to be easy to understand to be beneficial to all.

Second, I believe that professional societies should continue to develop position statements and white papers with summaries that are accurate.

As I mentioned earlier, the FDA has a wide variety of educational materials for both the healthcare professionals and patients.

In the future, it will be important to incorporate knowledge around biosimilars into the curriculum of pharmacy, medical, and nursing schools. Once the healthcare practitioner understands biosimilars, their approval process, and their promise, these health professionals will become more accepting of these options, andnd better able to educate other folks.

BR&R: That’s a great point. I don’t have any knowledge regarding any schools of pharmacy today who are actually teaching or covering the biosimilarity question.

Yoon: I was invited as an alumni to speak at Purdue’s School of Pharmacy last year. Students’ level of interest in biosimilars was incredible; they had heard of them, but they had little knowledge about them. I don’t know whether other pharmacy schools have added it to their curricula. That’s something we have an investment in. We as manufacturers and payers should definitely promote and sponsor that.

BR&R: Let’s talk about Sandoz’s experience with Zarxio®. As you pointed out earlier the most successful biosimilar story in the four years of availability in the US. It has garnered a considerable share of filgrastim prescriptions since its initial launch in 2015. What do you believe is most responsible for that success?

Yoon: When we launched Zarxio in the US, we reached out to a wide variety of stakeholders across the healthcare continuum to address the barriers to biosimilar adoption. We also enacted a comprehensive medical strategy to reinforce the value of biosimilars overall. We have demonstrated that we saved the US healthcare system about $500 million dollars in less than 2 years and became the first biosimilar to surpass the reference biologic in market share—we’re nearly at 50%.

We now have eight biosimilars approved globally, with more  than 10 in the pipeline. We have also learned very valuable lessons that enabled us to bring biosimilars to the US.

There are multiple areas where the US has taken a different approach than the EU, including naming, interchangeability, and requirements for demonstration of analytical similarity. Aside from those different regulations, we continue to face numerous unique challenges in the US that are ultimately affecting patient access to life-saving biological medicines. We’ll continue to stay engaged in discussions about these challenges as well as other biosimilar policies that matter, and continue to help the environment for the development and access to these medicines.

BR&R: In the case of filgrastim, a follow-on medication (Granix®) preceded Zarxio in the marketplace by a couple of years. Do you believe the presence of Granix smoothed the way for folks to start thinking positively about the uptake of this new biosimilar?

Yoon: I would say no. Granix was approved via a completely different pathway as you know (the 351[a] pathway vs 351[k] for Zarxio). Granix is not a biosimilar product, and our challenges atSandoz with being the first to bring biosimilars to the US market were different than those faced by the manufacturer of Granix.

BR&R: My personal opinion is that in 2015, there was likely a good deal of misperception about the molecules and the approval process. The marketplace was in its infancy. My next question is a little more speculative. Sandoz is getting ready to enter into the pegfilgrastim marketplace with a biosimilar within the next few months. What marketing lessons, if any, do you hope to be able to apply with the pegylated biosimilar that you were able to successfully use to market Zarxio?

Yoon: The FDA has not yet taken action on our pegfilgrastim BLA resubmission and the review is still ongoing at the agency. We do remain confident in the quality of our dossier but I can’t comment on our upcoming marketing strategy or our commercial plan.

With that said, we’ll have to overcome several barriers to be successful. I can tell you that from the aspect of tens of thousands of people who undergo chemotherapy, it’s critical to have both the long- and short-acting filgrastim treatment options. Pegfilgrastim is made by adding polyethanolglycol to the filgrastim molecule. It can be attached to the drug molecule through a process we call pegylation. This slows down the elimination. It extends the half-life, so there’s a longer duration of effect.

We’ve already proven that biosimilars can create a massive savings in the US. In the year before the introduction of Zarxio, spending on filgrastim had increased by 4%. After Zarxio’s introduction, spending decreased by 28% through 2017, while the total volume only dropped by 13%.

BR&R: Thank you, William!

Pfizer Announces Launch Dates for Rituximab and Trastuzumab Biosimilars

At an earnings call this week, Pfizer’s CEO highlighted the impending launches of Ruxience® and Trazimera®, not long after the previously announced launch of Zirabev® (bevacizumab) at the end of this year.

The New York–based pharmaceutical manufacturer plans to begin marketing Ruxience in January 2020, and Trazimera February 15, 2020. This would make Pfizer first to market with a Rituxan® competitor. Pfizer follows Amgen to market with Trazimera, as Kanjinti® launched in July this year.

On the call, Albert Bourla, PhD, indicated that the company’s infliximab biosimilar (Inflectra®) had grown 8% for the third quarter of 2019 over the same quarter in 2018 (to $77 million). Inflectra’s marketshare in the US still remains below 10%, according to IQVIA.

A Profile of a Lesser-Known Player in the Biosimilar Space: Polpharma Biologics

On occasion, we profile some biosimilar manufacturers about whom our readers may not be familiar. This generally refers to companies with products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this post, we highlight a European company, Polpharma Biologics. The drug maker has centers in Gdansk and Duchnice, Poland; Utrecht, The Netherlands; and Zurich, Switzerland.

Polpharma Biologics

Established in 2013, Polpharma Biologics is a contract development and manufacturing organization that also develops its own biosimilars and biologics. Polpharma has several next-generation biosimilars and innovative therapies in its pipeline. Its CEO is Joerg Windisch, PhD, a 19-year former employee of Sandoz. The organization says on its website, “As biologics continue to advance the treatment of some of the most historically complex conditions, we are leveraging our large molecule capabilities to develop a number of biosimilars-biologic medicines that have no meaningful difference from their reference product in terms of safety and efficacy and are more affordable than the originator drug.”

Why you may be hearing more about this company: Polpharma is preparing a regulatory submission for its lead biosimilar, FYB201 (ranibizumab). The other biosimilar in clinical development is PB006 (natalizumab). Importantly, Polpharma Biologics secured a commercialization agreement with Sandoz for this agent, a biosimilar to Tysabri®. The company has just begun a phase 3 clinical trial, including 260 patients with multiple sclerosis, which is due for completion in August 2021.

In addition, Polpharma’s pipeline includes biosimilars for ustekinumab (Stelara®) and vedolizumab (Entyvio®), both in early stages of development. Polpharma is also interested in developing an innovative biologic agent for the treatment of autoimmune diseases and an immune checkpoint inhibitor (presumably as a cancer therapy).

New Legislative Proposals Offer Hope to Insulin Follow-on Manufacturers

This may be good news for partners Mylan and Biocon: Two bills are circulating on Capitol Hill that can alter the transition of insulins to biologic agents in March 2020. However, the timing for passage of these bills is questionable.

The Senate’s Affordable Insulins Approval Now Act (S.2103), a bipartisan bill that was introduced by Senator Richard J. Durbin (D-IL) in mid-July, has 13 cosponsors to date. It was referred to the Committee on Health, Education, Labor, and Pensions, where it awaits review.

Insulin transition
Senator Richard J. Durbin

Under this bill, a pharmaceutical company may file a 505(b)2 application for an insulin product before January 1, 2020 and still be evaluated via the abbreviated new drug approval pathway beyond the March 20, 2020 transition date. These filings are regulated under the Food, Drug, and Cosmetic Act, which governs the approval of nonbiologic drugs.

If S.2103 is passed, Mylan/Biocon, which received a complete response letter from the Food and Drug Administration September 25 for its follow-on insulin product, would not have to refile for approval under the 351(k) pathway as a biosimilar. Under the terms of S.2103, the insulin would only be transitioned to biologic status and regulated under the Public Health Services Act once approval has been obtained (regardless of when that occurred).

A separate House bill (HR.4244) was introduced in September by Representative Michael Kelly (R-PA). This proposal takes a different approach towards encouraging insulin copy development—completely removing the mandate to transition insulin copies to the 351(k) approval pathway. This bill, which has been referred to the House Committee on Energy and Commerce, does not have any cosponsors at present. Under Representative Kelly’s proposal, insulin copies would be carved out and continue to be regulated under section 505 of the FD&C Act.

The timing and current status of these bills make it seem unlikely they would be signed into law before the transition date of March 20, 2020. However, it is possible that actions of this type can be attached to other legislation that is further along. Companies like Mylan and Biocon certainly hope so, otherwise valuable time (having to wait until March 24, 2021 to apply as a biosimilar) will be lost in this regulatory “dead zone.”