Biosimilar Development Updates: BOTOX, RITUXAN, EYLEA

Below are some highlights of recent news in biosimilar development:

Earlier this week, Mylan and Revance Therapeutics, who are collaborating in developing a biosimilar of BOTOX (onabotulinumtoxinA), reported on their quarterly earnings calls that they participated in an initial advisory meeting with FDA at which the agency provided guidance on its expectations for a development program to establish biosimilarity to BOTOX.  On February 24, 2019, Mylan’s President Rajiv Malik stated that, “[b]ased on agency’s feedback, the companies believe that the 351(k) pathway for the development of the biosimilar to BOTOX is viable and provides the opportunity to develop and commercialize the first biosimilar to BOTOX.”  On February 26, 2019, Revance’s President and CEO Daniel Browne added that “[s]uccessful completion of a biosimilar program could potentially result in approval for all eleven FDA-approved BOTOX indications.”  Mr. Browne further stated that, “[a]fter review of the final advisory meeting minutes, expected in March, Mylan and Revance will plan to discuss the development path, timing and next steps.”

On February 22, 2019, China’s National Medical Products Administration (NMPA) approved China’s first biosimilar drug, Shanghai Henlius Biotech’s HLX01, a biosimilar of RITUXAN (rituximab).

Also on February 22, 2019, it was reported that Korea-based Alteogen had submitted an investigational new drug application for ALT-L9, a proposed biosimilar of EYLEA (aflibercept), to Korea’s Ministry of Food and Drug Safety.  According to the report, Alteogen “plans to conduct a randomized, double-blinded and actively controlled clinical study, which will evaluate the safety, efficacy and pharmacokinetic of ALT-L9 in patients with neovascular age-related macular degeneration” in comparison to the EYLEA reference product.

On February 26, 2019, cell line developer Selexis SA and Istanbul-based Turgut Pharmaceuticals announced that they “signed two commercial license agreements (CLAs) through which Turgut will leverage Selexis’ SUREtechnology Platform™ and SURE CHO-M Cell Line™ for the development of two high-quality biosimilar antibodies: a checkpoint inhibitor for the treatment of certain cancers and a monoclonal antibody for the treatment of metastatic HER2-positive breast cancer.”

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