Blog Big Molecule Watch August 13, 2019

Biosimilar Development Updates

Below are highlights of biosimilar development news from the past couple of weeks:

On August 5, Revance Therapeutics indicated on its quarterly earnings call that it has continued to have discussions with its collaborator Mylan about their proposed biosimilar of BOTOX (onabotulinumtoxinA) since their initial advisory meeting with the FDA this past February. On the call, Revance’s CEO Daniel Browne acknowledged the challenge that would be involved in developing the biosimilar, but reiterated that it was “not impossible” and that Revance continues to believe that “a biosimilar pathway for onabotulinumtoxinA is viable.” Mr. Browne further explained that Mylan has “an opportunity to opt-in or opt-out” of the collaboration, but Revance still views the proposed biosimilar candidate as “an asset” regardless of what Mylan decides to do or “whether a biosimilar to BOTOX makes sense in [Mylan’s] portfolio or not.”

On August 2, Momenta announced that it would “cease active development of M923,” its proposed biosimilar of HUMIRA (adalimumab). Momenta had previously reported that it was prepared to submit its aBLA for this biosimilar candidate, but delayed submission as it worked out the details for potential commercialization and after it obtained a license from AbbVie. On the company’s recent quarterly earnings call, CEO Craig Wheeler explained that Momenta had “been unable to secure a commercial partner for this program” and “believe[d] it [to be] prudent to cease ongoing investment in M923 at this time,” particularly given that “the market opportunity has changed significantly with recent settlements, ensuring that up to eight players will be launching at once.” Mr. Wheeler stated that “the decision to discontinue activities on M923 will save [Momenta] approximately $100 million in anticipated cost to launch the product, which can now be allocated to our promising novel programs.”

Momenta, however, is not discontinuing all biosimilar development. Momenta reported that it was continuing with clinical development of M710, a proposed biosimilar to EYLEA (aflibercept) that it was developing in collaboration with Mylan. According to Mr. Wheeler, “Mylan is currently enrolling patients in the Phase 3 study to this product, and we continue to believe that we have the opportunity to launch in the U.S. as early as 2023.” Mr. Wheeler further stated that Momenta is “currently in the lead for developing this asset and believe[s] M710 could bring in significant revenue to support our expanding novel pipeline and we look forward to keeping you update here as this trial progresses.”

On August 1, Biocon and Mylan announced that they had launched OGIVRI, a biosimilar to HERCEPTIN (trastuzumab), in Australia. The companies’ press release states that “Ogivri is the first trastuzumab biosimilar approved and launched in Australia and available on the Pharmaceutical Benefits Scheme (PBS).”

On July 29, Alvotech and Cipla Gulf FZ LLC announced that they had entered into an exclusive partnership for the commercialization of AVT02, Alvotech’s adalimumab biosimilar candidate, in select emerging markets. According to the press release, “Alvotech will be responsible [under the agreement] for development and supply of the product, while Cipla Gulf will be responsible for registration and commercialization.” The companies state that AVT02 is currently in Phase-3 clinical development, with target filings with the EMA and U.S. FDA by early 2020. As we previously reported, Alvotech has entered into collaborations with other companies to develop its biosimilar portfolio in other jurisdictions, including Japan and Turkey.

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