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
PRICING COMPARISON FOR PEGFILGRASTIM REFERENCE AND BIOSIMILARS
*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
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.
“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
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.
“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
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.
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.”
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,
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.
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.
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.
The secret is in the sauce that makes Kaiser Permanente a
truly integrated payer, and in its devout avoidance of the Achilles heel of
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,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.”
adherence is about 95%, according to Dr. Gutierrez, and in California, “the
plan does not require prior authorizations.”
The Looming Patent Cliff
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.”
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
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
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.
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.
(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.
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.
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 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.
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.
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.
& 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.
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
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
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.
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.
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
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
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
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
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
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%.
At an earnings call this week, Pfizer’s CEO highlighted the
impending launches of Ruxience®
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.
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.
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.
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
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.
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