Biosimilar Bytes This Week

The Institute for Clinical and Economic Review (ICER) released a report this week that highlighted seven pharmaceuticals with “substantial price increases on top of already high current spending.” According to ICER, these seven agents accounted for billions in unnecessary expense in 2017 and 2018. AbbVie’s Humira® and Genentech’s Rituxan® topped the list, with Neulasta® coming in at number 5. The first two are not that surprising, because relatively high price increases (even net rebates or other considerations) are common reactions of pharma companies to imminent new competition. This has been typical for small molecule brands facing patent expiration and generic challenges. In 2017 and 2018, AbbVie may have been more concerned that it could not reach a settlement with the several biosimilar manufacturers working on adalimumab agents. Genentech also faced similar conditions with Rituxan. On the other hand, Amgen was already facing strong competition from Zarxio® and Granix®.

ICER specified,Net price increases for the seven drugs unsupported by new evidence were responsible for increasing total US drug spending by more than $5.1 billion from 2017 to 2018. The drug whose price increases accounted for the greatest single impact on spending was Humira. Humira’s average US price increased 15.9% over this period.I emphasize, this was net price not list price increases.

In a presentation at the Drug Information Association (DIA) annual meeting, Janet Woodcock, MD, Director of the FDA’s Center for Drug Evaluation and Research, stated that 83 biosimilar development programs were now ongoing, for a total of 38 different biologics. This implies that biosimilar interest in several new classes of biologics remains strong from established and prospective manufacturers.

Tanvex BioPharma announced in late September that its TX-01 filgrastim biosimilar candidate was not approved by the FDA. According to Tanvex, the FDA’s complete response letter did not cite any data deficiencies that might require additional studies. This leads one to suspect that production facilities problems may be the issue. The soonest Tanvex can expect a new FDA decision is 6 months from its new application submission date. As a result, Zarxio® and Nevistym® remain the only two biosimilar filgrastim agents (plus the follow-on product Granix®) to compete with Amgen’s Neupogen.

Multiple Sources Announce Pfizer’s Intended Launch of Bevacizumab Biosimilar December 31, 2019

After coming to a settlement agreement (which may have been prodded by Amgen’s launch of Mvasi® in July), Pfizer can launch Zirabev® at the end of this year.

First reported by Aiden Fry at The Pink Sheet and confirmed by Kelly Davio at the Center for Biosimilars, the settlement between Genentech and Pfizer was signed September 19. It clears all remaining patent suits filed by Genentech (and its parent Roche), and if it follows the standard terms of previous agreements, pays a license to the maker of the reference product (Avastin®).

Amgen decided to launch Mvasi at-risk, gaining the advantage of being the first bevacizumab biosimilar available for prescription. The legal case brought by Genentech against Amgen hinges less on patent infringement but more on whether 6-month notice of launch was provided (or needed). The next step in this case is reportedly a trial sometime in 2020.

At least five other bevacizumab biosimilars are actively being investigated, but none of these are likely to be approved in 2020 (none have filed 351[k] applications to date).

The Potential Effect of Amgen’s Launch on Biosimilar Licensing Deals

Imagine this interesting and perhaps very real-life scenario. It could have several implications for the present biosimilar marketing picture.

Biosimilar licensing deals

A reference manufacturer, we’ll call them Arby, signs multiple licensing deals with biosimilar manufacturers, to launch their products sequentially in 2025. The licensing deals all conclude outstanding patent litigation between the parties. But one biosimilar manufacturer doesn’t sign. We’ll call them Brooklyn Industries (BI for short).

Despite Arby’s contention that its patents on the reference product Yultira are valid until the year 2045, BI decides to launch at risk in July 2020. According to the phased launch schedule, another manufacturer, Thousand Oaks, was supposed to have the first biosimilar available on the market, with a three-month jump on the other seven competitors. Does that really give BI a five-year start over all of its competitors? And what if BI had an interchangeable biosimilar designation? Would that enable them to lock up the marketshare?

Biosimilar Licensing Deals: The Acceleration Effect

This scenario is actually playing out today with Amgen’s launch announcement of its trastuzumab and bevacizumab biosimilars (Kanjinti® and Mvasi®, respectively). Other manufacturers, including Pfizer, Samsung Bioepis, Mylan/Biocon, Teva/Celltrion have licensing agreements in place with Genentech (a subsidiary of Roche) for launch of their Herceptin® biosimilars. Only Amgen’s Mvasi and Pfizer’s Zirabev® are approved (so far) to compete for the bevacizumab business. The details of the licensing deals signed by Roche have not been released publicly, so we do not know when the first “authorized” biosimilars were supposed to launch. Conjecture abounded that it would be in 2019, nevertheless.

How does Amgen’s Kanjinti launch affect the licensing agreements that were signed with Roche? Does it mean that Amgen gets a substantial head start on the competition? Do the licensing contracts consider this possibility?

According to Kevin M. Nelson, JD, at the Chicago-based law firm Schiff Hardin, this scenario is considered in a typical pharmaceutical licensing arrangement. “Typically, settlement agreements in the pharma space include what are called acceleration clauses. Such clauses will allow an agreed-upon launch date to be accelerated to an earlier date in the event the patent or patents are invalidated or found not infringed in another litigation, or if a competing product or authorized competing product comes on the market before that agreed-upon date.”

Biosimilar licensing deals
Kevin M. Nelson, JD

He added that these acceleration provisions “can come in a variety of flavors from a change in royalty rate or structure, a requirement to leave the market if the ‘unauthorized entrant’ leaves the market, or perhaps agreed damages.” 

Accelerating Clauses Are One Thing. Accelerating Launch Is Another Matter

The fact that Amgen has announced its immediate launch may present more pragmatic problems for the other manufacturers, Mr. Nelson pointed out. Let’s say that you were a member of the Mylan/Biocon team. Your product was approved more than 18 months ago (the first one approved). Let’s also say that your licensing agreement with Genentech allowed you to launch after November 1 (a purely speculative, arbitrary date). Finally, assume that your licensing agreement was generous: it allowed you to launch as soon as possible after another competitor jumped the starter’s gun. Is it feasible to launch immediately, perhaps four months early?

“The biosimilar companies cannot just fire up the machines and have product ready tomorrow,” stated Mr. Nelson. There are all of the logistical issues surrounding a launch that must be considered: “Manufacturing, packaging, sales, and distribution all take time,” he said. “And you don’t want inventory to go bad—especially not this type as it is expensive. They may have some reserve lots or made small batches just in case, so we could see a trickle into the market.”

Remember, also, that payer and health system contracts are not arrived at overnight. Even if the Mylan/Biocon team did have lots available for shipment, they might not have places in the US to ship, other than to a group purchasing organization or distributor’s warehouse.

Typically, payers will not cover pharmaceutical agents outside of medical exceptions before the Pharmacy & Therapeutics Committee review, and this can happen anytime between 60 days and 9 months of the launch. And this is not a product that will revolutionize therapy or immediately fill an unmet clinical need. Only large discounts can move the needle here, and establish a contract quickly. Therefore, the anticipated short window of opportunity that Amgen may have in launching Kanjinti may get a little shorter but perhaps by not much.

When I mentioned the Arby, er Abbvie, scenario, Mr. Nelson agreed that it would be an entirely different ballgame. Had Boehringer Ingelheim decided to enter the market (as an interchangeable or not), their launch “would have caused absolute chaos.” Imagine trying to pull forward launch date plans of seven manufacturers by three years!

Amgen/Allergan Partners Announce Launches of Herceptin and Avastin Biosimilars

The partnership of Amgen and Allergan made a huge splash in the biosimilar market by announcing the simultaneous US launches of the first two biosimilars of anticancer monoclonal antibodies. The agents Kanjinta® (trastuzumab-anns) and Mvasi® (bevacizumab-awwb) were officially made available July 18.

The move occurred almost simultaneously with a court denial of Genentech’s request for a restraining order against Amgen. For Amgen, this marks the first two biosimilars to reach commercialization.

The launch discounts associated with these two agents is only 15% off of average wholesale price (AWP), but the manufacturers point out that is still significantly below the average selling price (ASP) of the two reference drugs—13% lower than that for Herceptin® and 12% lower than that for Avastin®. This pricing does not include potential rebates or discounts that could further reduce the net costs of these biosimilars.

The launch timing raises the question of when the FDA-approved biosimilar competition will be launched. Other biosimilars in the trastuzumab space have signed licensing agreements with Genentech, the maker of Herceptin. Their launch dates have not been disclosed. Several biosimilar makers have also signed licensing agreements with Genentech on their versions of Avastin, and their launch dates may be upcoming as well.

Assuming the licensing agreements compel the other manufacturers to pay some percentage of sales or profits to Genentech, this could give Amgen/Allergan an automatic edge in profitability. It is unknown whether the launch timing of Mvasi and Kanjinti, have any implications for the existing licensing agreements. For example, it may be possible that an early launch by an unlicensed competitor could negate specific clauses of these contracts.

The bevacizumab biosimilar class progress had stagnated through court proceedings and licensing agreements. In a post from January 2019, we had noted that Amgen had notified the court that it was prepared to launch as early as April 2018.

On the trastuzumab side, Amgen/Allergan’s product was the most recently approved biosimilar (in June 2019).

In their joint press release, they quoted Paula Schneider, CEO of the Susan G. Komen Breast Cancer Foundation. “The introduction of biosimilars is an important step in increasing options for treating HER2-positive breast cancers, which account for about 25% of all breast cancers,” she said. “As patient advocates, we are working to ensure that patients are educated about biosimilars and understand that these FDA-approved treatments are just as effective as the original biologic drugs.”

A Profile on Lesser-Known Player in the Biosimilar Space: Formycon AG

On occasion, we profile some biosimilar manufacturers about whom our readers may not be as familiar as the large players like Sandoz, Amgen, and Pfizer. This generally refers to companies that have products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this updated post, we highlight a German company, Formycon AG, which has eyes on the US marketplace.

Formycon acquired Scil Technology GmbH in 2012, and hired a new CEO the following year. Carsten Brockmeyer, PhD, has extensive experience in the biosimilar field, previously helping Hexal Biotech to develop EPO and filgrastim biosimilars for the European market.

Why you may be hearing more about this company: Formycon has two principal biosimilar targets, ranibizumab and ustekinumab. The company disclosed that “it successfully completed a Type IV pre-submission meeting with the US Food and Drug Administration (FDA) in December 2018 and clarified other pivotal issues. The filing with the FDA for the approval of FYB201 is expected at the beginning of the fourth quarter of this year.” A filing for the European Medicines Agency is planned for 2020. A phase 3 clinical trial of this agent was completed in June 2018. In the development of this agent, Formycon partnered with Bioeq GmbH, but it is unclear whether a marketing partner exists for a possible US launch.

The patent for ustekinumab (Stelara®) expires in 2023 (US) and 2024 (Europe). It is partnered with Aristo Pharma GmbH on the manufacture and testing of this interleukin 12/23 inhibitor (also known as FYB 202).

Formycon is in the early stages of developing a phase 3 trial for its biosimilar version of Eylea® (aflibercept or FYB 203), the next generation of macular degeneration treatment. It is partnered with Santo Holding GmbH on the development of aflibercept.

In other biosimilar news… Amgen decided to pull its EMA application for its infliximab biosimilar, likely due to market competition. The company has not taken similar action with regard to an FDA application for the same product, ABP 710. Considering that neither Samsung Bioepis or Pfizer failed to gain traction in the US marketplace for infliximab, Amgen must think that some biosimilar infliximab marketshare growth in the US is still possible.

Introducing the 21st FDA Approval: Pfizer’s Zirabev, a Biosimilar of Avastin

On June 28, 2019, Pfizer announced that it had received Food and Drug Administration (FDA) approval of Zirabev™ (bevacizumab-bvzr), a biosimilar version of Roche’s Avastin®.

Pfizer approval of Zirabev

Based on the evidence provided by Pfizer, including its phase 3 trial comparing it to the EU-licensed version of Avastin, the FDA approved Zirabev for five cancer indications, including:

  • Advanced, metastatic, or recurrent nonsquamous non–small cell lung cancer
  • Metastatic colorectal cancer
  • Recurrent glioblastoma
  • Metastatic renal cell carcinoma
  • Metastatic cervical cancer

This approval does not include ovarian cancer, which is an additional indication for Avastin. Belonging to a class of biologics called vascular endothelial growth factor (VEGF) inhibitors, these agents work by preventing new development of a tumor’s blood vessels, helping to choke off growth.

Zirabev’s approval marks the 21st FDA approved biosimilar agent and the second approval for a bevacizumab biosimilar. Mvasi®, to be manufactured by the partnership of Amgen and Allergan, obtained approval in September 2017. However, this product is not yet marketed.

At a recent annual meeting of the Academy of Managed Care Pharmacy, a specialty drug pipeline expert expressed hope that Mvasi would be launched in July of this year. Its manufacturer has been embroiled in patent litigation with Roche, but the key patents are expected to expire in the immediate future.

Pfizer has not announced a launch date for Zirabev. Yet, it could be the second cancer-treating biosimilar category to enter competition (with Herceptin biosimilars) very shortly.

Don’t Expect All-Out Biosimilar Competition for Herceptin—Just Yet

Five trastuzumab biosimilars have been approved for marketing in the US, and the composition-of-matter patent for the reference product, Herceptin®, expires June 30, 2019. That doesn’t mean we’ll see a jail break of competition, like that seen in the EU last October with adalimumab’s patent expiration. Yet there has been heavy interest in capturing a slice of Herceptin’s $2.9 billion US sales (in 2018).

Three manufacturers have signed licensing agreements with Genentech (subsidiary of Roche). In March 2017, Mylan signed the first agreement for its product Ogivri®. Its marketing partner is Biocon. In December 2018, Pfizer followed suit for its recently approved agent Trazimera®. None of the parties have indicated when a biosimilar agent will be launched. At the end of December, Celltrion and Teva came to a similar agreement on its Herzuma® biosimilar.

Herceptin patent litigation

According to Goodwin’s Big Molecule Watch, Roche’s infringement claims against Samsung Bioepis (Ontrusant®) and Amgen/Allergan (Kanjinti®) are still being litigated. For Genentech v. Samsung, the bench trial is slated to begin December 9, 2019. In addition, Samsung Bioepis is appealing the Patent Trial and Appeals Board ruling regarding the validity of Herceptin’s method of use patents. Separately, Genentech is challenging the PTAB’s decision that two other Herceptin patents were invalid. There’s a whole lot here that needs to be resolved (or settled).

In the case of Amgen and Allergan, Genentech originally brought suit claiming 38 patents were infringed (in June 2018). In July 2018, Genentech reduced this figure to less than half (17). A month later, Amgen responded to the suit. Little information is available on timing of next steps.

Based on this information, it is difficult to know just when the first trastuzumab biosimilars will be launched. If Genentech followed Abbvie’s example in its 2023 sequencing of adalimumab biosimilars, one might expect Mylan’s product to be available first, perhaps as early as this summer, with Pfizer’s and Celltrion to follow perhaps six months later.

Yet, unlike the Abbvie agreements, none of the Genentech licensing settlements were made public (other than the actual dates of the agreement). Keep in mind, Herceptin was first approved by the FDA in October 1998. In 2018, the drug’s sales in the US and EU combined was over $4.7 billion. Is 21 years of market exclusivity to anyone’s benefit, other than the manufacturer? Since 2006, US drug sales of Herceptin have been greater than $1 billion annually. If the biosimilar launches do not occur shortly, this may be a good test case of the Federal Trade Commission’s commitment to clearing patents in the name of competition.

Does Mass Signing of Adalimumab Licensing Deals Add Up to Biosimilar Access Collusion?

As reported by the Center for Biosimilars, a union has filed a class-action lawsuit against AbbVie and the eight prospective biosimilar adalimumab makers who agreed to delay bringing their agents to market through a royalty arrangement.

Only Boehringer Ingelheim remains as a biosimilar maker who has an approved version of adalimumab but who has not signed on with AbbVie. United Food and Commercial Workers Local 1500 has filed the suit with the other manufacturers and AbbVie, claiming that by their actions, they are trying to “divide the market for adalimumab between Europe and the United States,” according to the Center for Biosimilars report.

This is an interesting question. The individual motivations of the first companies to come to agreement with AbbVie (Amgen, then Samsung Bioepis) included an end to interminable patent legislation in the US. They wanted the ability to immediately plan launches in Europe (starting in October 2018). The motivations of most other subsequent signees almost certainly was to not forfeit marketshare in Europe, which was needed to help sustain biosimilar development efforts for the US market. In fact, many of these prospective US manufacturers already had received approval in the EU.

AbbVie’s principal patents on Humira® expired in Europe in October 2018. The last of the principal patents are supposed to expire around 2023 in the US anyway. Was it necessary to arrange serial US launches as demonstrated in this link? Would patent litigation have continued well past the supposed patent expiration date? Knowing AbbVie, this is likely. Their several patents involving adalimumab use to treat individual diseases would provide AbbVie a basis for forging ahead with lawsuits that would have gained them additional billions of dollars in sales while the suits meandered toward conclusion.

Does this mean that access to Humira is accelerated through the signing of the royalty agreements, rather than delayed through acts of collusion? That is difficult to say. Although should the lone holdout—Boehringer Ingelheim—decide that it makes business sense to launch at risk, it could topple the carefully orchestrated structure of the agreements. Amgen believes that it will launch the first adalimumab biosimilar, and experience a few months of exclusivity in the US. At that point, Amgen (and every subsequent adalimumab biosimilar maker) would have to decide whether (1) to do the same or risk losing its advantage, (2) start working towards marketing plan B, or (3) cede the initial marketshare and its billions in revenue and wait it out. If Boehringer obtains its sought after interchangeability designation, that may well speed up the process.

Personally, I find it hard to believe that these individual acts represent premeditated collusion; although the resulting lack of access to the many biosimilar versions may look to others as an orchestrated maneuver.

A Conversation With Doug Long, IQVIA

Doug Long, Vice President of Industry Relations at IQVIA (formerly QuintilesIMS), spoke with us about some of the intracacies of the filgrastim and pegfilgrastim marketplace, and regarding improving access to biosimilars in general. 

Doug Long
Doug Long, IQVIA

BR&R: Do you think interest by manufacturers in biosimilars is gaining or waning at this time?

Doug Long: It’s somewhere in between those two. A lot of people are staying in the game to see how it plays out. Maybe discouraged most accurately describes their feelings at this time. They are discouraged, because there are 17 approved products but only 5 are available. And the uptake of those on the market is not that great, particularly compared with the uptake in Europe.

BR&R: I can see how manufacturers and payers would be discouraged right now. You’re right, in the European market, we’ve seen a great deal of uptake and significant discounting as well. So many factors affect biosimilar coverage and uptake. It may also relate to the individual biosimilar’s disparate marketplace situations.

DISTINCT MARKETS FOR BIOSIMILAR DRUGS

In the US, based on the utilization numbers seen today, do you believe the infliximab, filgrastim, or pegfilgrastim markets will best characterize how other biosimilars (e.g., Avastin® or Herceptin) will perform when available?

Long: Well, with the filgrastim molecule, you need to look at both filgrastim and pegfilgrastim, and their routes of administration (prefilled syringes and on-body injectors). Granix® and Zarxio® have the majority of the dollar share on the filgrastim side. It’s too early to tell on the pegfilgrastim side, though Amgen has a 61% share of that Neulasta® molecule with its Onpro® formulation. The addressable market for the molecule is really only the remaining 39%.

You also have to make a distinction between how much of the market is controlled by the pharmacy benefit managers compared with the hospital group purchasing organizations (GPOs) or buying groups. Most of the filgrastim and pegfilgrastim is controlled by the hospital buying groups, and that’s also going to be the case for the cancer-treating biosimilars. There’s no doubt in my mind that when Humira® or Enbrel® are available, the PBMs will embrace the biosimilars. There are just so more complexities on the hospital side of the market that it makes it more difficult for them to move towards the biosimilars.

DEEPER INTO THE FILGRASTIM/PEGFILGRASTIM SCENARIOS

BR&R: There’s an interesting situation brewing in the filgrastim market. The success of Granix and really Sandoz’s Zarxio penetrating the market has contributed significantly to the drop in total sales revenues for filgrastim sales combined. However, how much of this decrease is attributable to migration to pegfilgrastim, and Neulasta Onpro in particular?

Long: Sure, look at their revenues today. Filgrastim is at $611 million in annual sales and pegfilgrastim is at $4.3 billion. Of that $4.3 billion, Onpro accounts for 61%.

BR&R: At Coherus’ fourth-quarter earnings conference call, their CEO indicated that he thought the Onpro marketshare might be vulnerable to the pegfilgrastim biosimilar, which is available today in prefilled syringes. Obviously, that would mean selling Undenyca® at a more enticing price, below the 33% discount currently offered. Do you think that Onpro sales erosion is likely or does the formulation offer real value?

Long: That could work, but the thing about Onpro is that when you finish your chemotherapy for the week, they put the injector on you and you don’t have to go back to the doctor’s office for a pegfilgrastim injection the next day. That’s one of the reasons it is as popular as it is—it reduces hospital and doctor expenses at the end of the day, and is more convenient for the patient.

BR&R: Biosimilar manufacturers like Coherus have expressed interest in developing its own on-body injector for its biosimilar. It seems to present distinct advantages. Does that mean that the biosimilars will be relegated to fighting only for that prefilled syringe market, the remaining 39% of utilization?

Long: It’s probably too early to say. Fulphilia® has only been marketed since July, and the other one [Udenyca] was launched only recently. We’ll have to see what kind of uptake it gets. Also, we’ll have to see what happens when other players come to the market. The more drugs you have available, the more share erosion from the originator you’ll likely see. Yet that did not happen with Remicade…

BR&R: That may be more of a special situation, considering the actions taken by Janssen Biotech to prevent coverage of both Pfizer and Merck’s products.

The filgrastim/pegfilgrastim markets are also different for that reason: Amgen did not aggressively defend their market share on the prefilled syringe originator products (i.e., Neupogen® and Neulasta). Rather, they focused on getting conversions to Onpro. So the biosimilar manufacturers were not facing aggressive defensive tactics, like those employed by Janssen. 

Long: Yes, but they will defend Onpro as much as they can.

BR&R: And Amgen established Neulasta and the Onpro formulation at the same price point.

Long: It made sense. It was a good defense mechanism.

BR&R: It does force the biosimilar manufacturers to work harder to gain business.

AN UNCLEAR FUTURE

BR&R: The Administration has several initiatives that may directly or tangentially affect the biosimilar market. These include the Medicare International Pricing Index, the move to place Part B drugs into Part D (and allow step therapy and other UM tools), the reevaluation of drug rebate safe harbors, and of course, the individual components of the Biosimilar Action Plan. Do you think this will ultimately result in artificial price deflation? Would that be helpful or harmful to biosimilar makers?

Long: That’s a question that I really don’t have an answer for. Who knows what’s going to happen? People have started to make moves to reduce WAC prices, like Amgen on their PCSK9 inhibitor and Gilead on their hepatitis C treatment. Gilead created an “authorized generic” to reduce its price dramatically.

People are starting to play around with it. Maybe to get adopted, a biosimilar maker may actually have to raise their drug’s WAC price higher than the originator, and then give a larger rebate.

More Adalimumab News: Abbvie Signs a Licensing Deal With Coherus, Coherus Sues Amgen for Patent Infringement

The multitude of companies that have lined up to sign 2023 licensing agreements with Abbvie on sales of Humira® biosimilars has grown again. The latest biosimilar maker added to the list is Coherus Biosciences.

Coherus adalimumab biosimilar

Coherus has an investigational adalimumab biosimilar that completed a phase 3 trial in 2017 in patients with plaque psoriasis and psoriatic arthritis. CHS-1420 was found to yield similar clinical outcomes compared with the reference product.

According to the press release from Coherus announcing the deal, the biosimilar will be available for marketing December 15, 2023. This will make it the eighth biosimilar version of adalimumab to enter the market, with Amgen entering first, in January of that year. As with the other deals signed by Abbvie, this signing concludes any patent litigation between the parties and Coherus will pay royalties to Abbvie on the sales of its biosimilar.

Coherus is expected to file a submission with the European Medicines Agency, though the timing of this filing has not been disclosed. Furthermore, it has not yet signed a deal with a marketing partner. In past conference calls, the biosimilar maker has indicated that it will not focus its resources on sales of its products outside the US.  

COHERUS SUES AMGEN OVER ADALIMUMAB PATENTS

To complicate matters a bit more, Coherus has launched a patent infringement suit against Amgen, believed to be the first of a biosimilar maker against another. Amgen’s Amjevita® was approved by the Food and Drug Administration in 2016, and has been for sale in the EU. Coherus intends to file for FDA approval in Q4 2019. Coherus contends that Amgen’s manufacture of Amjevita violates Coherus’ US patents 10,155,039; 10,159,732; and 10,159,733. These patents involve the creation of stable aqueous formulations of adalimumab.

Coherus seeks “damages adequate to compensate for past, present, and future infringement,” which could have implications for revenues from the European sales of Amgen’s biosimilar, because of its manufacture in the US. In addition, Coherus seeks an injunction from the court that permanently enjoins Amgen from engaging in further alleged infringement.  

Coherus President and CEO Denny Lanfear said in its January 25th press release, “Coherus recognized early on the central role intellectual property would play in advancing biosimilars to market. One important element of our IP strategy for advancing [CHS-1420] is reflected in the success we’ve achieved in patenting our innovations in the field of adalimumab formulation. We believe in the strength of our IP and we intend to protect it.”

Although generic manufacturers engaging in patent suits with competitors has occasionally occurred, this may be a first in the biosimilar community. I suppose it was only a matter of time.