Revance Therapeutics, Mylan, and Formycon Announce Updates to Their Biosimilar Plans

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Revance Therapeutics, Mylan, and Formycon have announced updates to their biosimilar plans.  In the Q1 2020 Earnings Conference Call on May 7, 2020, Revance updated investors on the biosimilar to BOTOX® program in potential partnership with Mylan.  Revance informed investors that Mylan had requested additional information from Revance, and would make a decision as to the partnership by the end of May.  Revance stressed that Mylan was a “great partner,” and that it was confident in the Revance-Mylan biosimilar program.  In Mylan’s Q1 2020 Earnings Conference Call on May 11, 2020, Mylan affirmed that it would provide an update on the path forward for the Revance-Mylan partnership by May 31st.

Further, in the Q1 Earnings Conference call, Mylan announced several key pipeline updates, including FDA pre-approval of its partner Biocon’s Malaysia manufacturing facility, a planned launch for Nepexto (Mylan’s biosimilar to Enbrel®) in Europe, and review with the FDA and European authorities of the Biologics License Application and marketing application for the biosimilar to Avastin®.  Mylan’s development of a biosimilar to Aspart® and Eylea® remains on track, and follows launches for Fulphila, a biosimilar to Neulasta®, and Ogivri, a biosimilar to Herceptin®, in the United States, as well as Hulio, a biosimilar to Humira®, in Europe.

In response to ongoing market shifts due to Covid-19, Formycon reassured its investors in a May 15, 2020 press release that due to early implementation of organizational decentralization measures, its operating schedule remains intact with minimal changes, and that the company’s liquidity is unaffected.  Formycon provided an update on its biosimilar candidate for Lucentis®, for which it is generating additional manufacturing data requested by the FDA for resubmission, which is expected in the second half of 2020 by license partner Bioeq AG.  Additionally, Formycon is preparing for a fall 2020 phase III clinical trial for its biosimilar of Stelara®, and a mid-2020 Phase III clinical trial for its biosimilar to Eylea®.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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