Tag: Momenta

Momenta Drops Out of Biosimilar Adalimumab Competition

In reporting its second quarter earnings, Momenta Pharmaceuticals stated on August 2 that it no longer plans to market M923, its biosimilar version of Humira®.

“Today, Momenta announced the Company will cease active development of M923 at this time, due to changes in the market opportunity associated with Humira patent litigation settlements,” according to a company press release.

In 2018, Momenta decided to drastically scale back its biosimilar development as part of a strategic review. However, it continues to partner with Mylan on one remaining biosimilar candidate, M710. This is a biosimilar version of aflibercept (Eyela®).

Momenta’s troubles were first apparent after it completed its phase 3 trial of M923 in psoriasis. The clinical study pitted the biosimilar versus the EU-licensed version of adalimumab, and was successfully completed in 2017; however, no FDA filing ensued, despite a company announcement that it would occur in 2018. Later that year, the company stated that it delayed filing for financial reasons, but it would continue to seek a partner to commercialize the product.

In 2018, it signed a licensing agreement with AbbVie, which would have allowed it to launch in December 2023—in the back of the pack of licensed biosimilars in terms of timing (which could not have helped its efforts to seek a partner). In view of its refocusing its strategic outlook, the delay in filing a 351(k) biologic licensing application (BLA) application with the FDA may have made some sense from a couple of perspectives

First, the company may have thought twice about continuing expenditures if it was undecided as to whether it would remain committed to the biosimilar development. These expenditures could be quite significant (beyond payment of user fees) if the FDA requested additional data in an initial review of the BLA.

Second, with a potential launch date of December 2023, Momenta certainly had time to get its ducks in a row. If a commercialization partner could be lined up before the BLA filing, that company could help shoulder additional associated costs.

In any case, Momenta’s pull back is not entirely unexpected. Though it intended to file an application with the European Medicines Agency early this year (which would not have required a further delay in launch), this also did not occur (probably because of existing biosimilar adalimumab competition in Europe).

Momenta’s pipeline, beyond aflibercept, consists of other biologics for rare diseases. Its marketed products are for generics of Copaxone® and Lovenox®.

A Quick Look Back: Why We Misread the Signs

In the biosimilars arena, at least in the US, history seems to be truncated. Policy changes occur in rapid fire succession these days, and access scenarios don’t evolve—they just happen or they don’t! Along this brief journey, I’ve taken the opportunity to focus on some of the sign posts that were exceedingly poor maps for navigating the future.

One of the first blogs I wrote for The Center for Biosimilars in early 2016, involved a defeat for Amgen in its patent litigation with AbbVie regarding Humira®. No one was sure what the implications of this decision would be. Amgen was on the road to gaining approval of the first biosimilar adalimumab. The payer and investment community sensed momentum building towards the imminent takedown of the number 1 biologic in terms of sales. I referenced 2016 Humira revenue estimates of $14 billion for AbbVie, and mentioned two other prospective biosimilar makers—Baxalta and Momenta—being hot on Amgen’s heels.

In that same article, many in the investment community was under the belief that a US marketed adalimumab biosimilar would be available by 2020. Instead, January 2023 is looking more inevitable. I wrote, “The investment community believes that Amgen will come out on top; they believe that AbbVie will have $6 billion—not $18 billion—in Humira sales by 2020.”

I’m not sure that I could have been more wrong in my assumptions or sentiments, thinking that AbbVie’s maze of 70 patents (at the time) could be severely damaged at that time by the process to challenge patents. This may happen today through Boehringer’s efforts, but I wouldn’t count on it. The other major players don’t have the stomach for fighting this battle.

In 2017, Baxalta and Momenta have dropped out of the biosimilar contention for Humira’s marketshare, replaced by Sandoz, Boehringer, Coherus, Samsung Bioepis, and perhaps others. Baxalta and Momenta , one being taken over by Shire and the other facing financial realities.

Unfortunately, it will take a miracle, in the form of a Boehringer victory or even less likely, adoption of Dr. Peter Bach’s biologic pricing proposal, to get adalimumab to the payer market. The fact that the proposal that Dr. Bach and his colleagues at Memorial Sloan Kettering laid out received as much attention as it did tells quite a bit about our serious frustration today with access to biosimilar savings.

Of course, very few actions taken by the current Administration have yet to be implemented. These are intended to bolster the biosimilar industry and move from promised to actual savings. However, the signs are telling me that we’re not in an evolutionary phase of biosimilar development–an extinction event may be around the corner.

Momenta Signs Licensing Deal With Abbvie. Did It Have a Choice?

We previously reported that Momenta Pharmaceuticals reevaluated its biopharmaceutical strategy going forward, deciding to move forward only with its investigational adalimumab and aflibercept biosimilars. Yesterday, Momenta announced that it has joined the long queue of pharmaceutical manufacturers signing a biosimilar licensing deal with Abbvie, which will allow commercialization of M923, its biosimilar to Humira, should it obtain regulatory approval. Momenta’s licensing deal is the fifth one signed by prospective biosimilar marketers in the US.

This agreement was pretty much a no-brainer for Momenta. The company did not have the stomach for attempting either an extended patent fight or an at-risk launch. However, the biosimilar licensing agreement only allows Momenta to market its adalimumab biosimilar in the US after December 2023, which will make it the fifth Humira biosimilar that will launch under the licensing agreements (Table). The main patents for Humira have expired in Europe, and these agreements have generally allowed the European launches to occur as of October 16 of this year.

Of the manufacturers signing biosimilar licensing deals with Abbvie , only Amgen and Sandoz have earned FDA approval for Amjevita® and Hyrimoz®, respectively. And Boehringer Ingelheim is still duking out patent litigation with Abbvie in the courts over its approved biosimilar agent Cytelzo®, for which it hopes to receive an interchangeability designation. The second through fifth agents entering the fight will be likely pounding away at subsequently smaller slices of revenue.

Perhaps the most frustrating part is that Abbvie is running a lucrative game; it will collect royalties from all of these manufacturers in 2023 and beyond, which will help offset declining marketshare from its biggest revenue contributor.

 

In Abbvie’s Web: Who Has Signed Licensing Agreements for Biosimilar Adalimumab?

Company/Partner

Drug Name

Launch Date

Amgen

Amjevita*

January 2023

Samsung Bioepis/Merck

SB5

June 2023

Mylan/Fujifilm Kyowa Kirin Biologics

Hulio

August 2023

Sandoz

Hyrimoz*

September 2023

Momenta

M923

December 2023
*Received FDA Approval.

Note: This post was revised and corrected, November 8, 2018.

An FDA Filing for Momenta’s Adalimumab Biosimilar Coming Soon?

Momenta seems to be in final preparations for its first 351(k) filing to the Food and Drug Administration (FDA). In its recent investor conference, the company disclosed that it is ready to send M923, its adalimumab biosimilar, to the agency for approval.

Momenta's Adalimumab Biosimilar
Craig Wheeler, CEO of Momenta Pharmaceuticals

Despite this promising news, Momenta is facing strong headwinds. Even if it gains approval, Momenta expects that the US launch of the adalimumab biosimilar will not occur until 2023, owing to pending patent issues with Abbvie’s Humira®. The company does not yet have a marketing partner for this agent, though there appears to be plenty of time.

In addition, Momenta received a setback in November 2017 on another looming biosimilar candidate, when its biosimilar version of abatacept failed its phase 1 trial. Apparently, its M834 produced pharmacokinetic results that differed from the originator Orencia® in this early clinical study. Momenta is still studying the data and trying to come to grips with the surprising findings.

The company is also set to begin “pivotal” clinical trials on its other drug candidate M710, a biosimilar to aflibercept. The originator product is Eylea®, and it is indicated to treat wet age-related macular degeneration.

Momenta’s partnership with Mylan is moving forward with preclinical work on four other nonspecified biosimilars, according to the company. But all of this development costs money, and Momenta has acknowledged that it may need to raise cash for future development.

Momenta received approval in January for a generic form of the multiple sclerosis drug Copaxone® (glatiramer acetate). The approval of this agent, produced in partnership with Sandoz, had been delayed because of manufacturing issues. The company recognizes that the entry of Mylan (ironically) into this market may hinder its financial outlook.

As a result of these developments, Momenta stated it would entertain a sale of its adalimumab biosimilar “or other assets.”

 

The Patent Games: Another Sequel Underway

Roche/Genentech has filed suit in Delaware, citing the alleged violation of 37 patents by Amgen in its intent to market its biosimilar version of Herceptin®.  

The litigation was filed in response to Amgen’s stated intention of launching their product in October 2018, based on a May approval. Unfortunately, the Food and Drug Administration decided not to approve Amgen and Allergan’s initial 351(k) application in early June.

Roche has been engaged with Pfizer and the team of Celltrion and Teva on their trastuzumab biosimilars as well.

Are We Now Thinking “Authorized Biosimilars”?

Authorized generics have been around for a couple of decades. They can be a challenge to payers, health systems, and patients who are seeking the price-reduction benefits borne out of normal competition. The Amgen–Abbvie agreementHerceptin on the biosimilar for Humira® seems to be right out of this playbook.

In summary, authorized generics work like this:

  • A brand manufacturer has a product that is nearing patent expiration
  • Rather than ceding its marketshare altogether in the face of multisource products, the manufacturer will come to an agreement with a generic drug maker to produce the first generic of its product, which allows the branded company to earn licensing fees and royalties on the drug
  • The additional royalty or licensing fee means that the price of the authorized generic will likely be higher than if there was no agreement
  • The maker of the authorized generic will get to market sooner (perhaps even prior to patent expiration)
  • Competing generic manufacturers will have to edge their way into the market against not only the authorized generic maker but perhaps the branded manufacturer that is benefiting from the agreement

On September 28, Amgen and Abbvie announced an end to the patent litigation between the companies. The agreement will allow Amgen to market its biosimilar (Amjevita™) in the US (in 2023) and in the EU (in 2019). The dates reflect differences in principal patent expirations for the two major markets. The all-important composition-of-matter patent expired in December 2016, which is why potential biosimilar manufacturers had hopes of marketing their products as early as 2017 in the US. The other patents don’t expire until 2023.

Under the agreement, Amgen acknowledges the validity of Abbvie’s myriad non–composition of matter patents on Humira and gives up the litigation fight to market its version of adalimumab. Amgen will pay Abbvie a licensing fee to market the product, similar to the type of deal for an authorized generic.

Presumably, Amgen entered into the agreement and did not launch at risk, because it feared that Abbvie would be able to successfully defend its patent maze in court. The agreement would allow Amgen to launch in the European market, which would sustain it during the wait to launch in the US.

However, Amgen is not the only potential maker of an adalimumab biosimilar. Boehringer Ingelheim has an approved product (Cyltezo™), which was approved in January 2017. Several other players are in later-stage trials, including (at least) Coherus Biosciences, Momenta Pharmaceuticals, Pfizer, Samsung Bioepis, and Sandoz. It is too early to tell what this agreement might mean for them. Might Abbvie be willing to make separate agreements with them as well, thereby ensuring itself of a cut of these profits for years to come?

In the biosimilar space, there is no exclusivity for the first biosimilar to market, and if a drug maker sought to launch at risk, the rewards can actually outweigh the potential penalties if they found themselves on the wrong end of ongoing patent litigation. Pfizer took the gamble with its Inflectra® biosimilar of infliximab.

If they have to wait until 2023 for this biosimilar, payers may decide to take action. One way would be to encourage the use of other anti-TNF inhibitors or even other effective biologic classes over Humira, if their pricing made sense. However, Humira is often preferred and significant rebates would be at stake.

Legislators did not account for the possibility of authorized biosimilars. It could be a further obstacle to making biologics more accessible to the people who may most benefit from their use.