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January 8, 2016 -- Biologics and Biosimilars Bits and Bytes

Revised Indian Biosimilar Guidelines Expected Soon

According to reports, the Indian Ministry of Health is planning on releasing revised guidelines on the approval of “similar biologics” sometime in February/March 2016.  India’s biosimilar guidelines became effective on September 15, 2012.  It is believed that the revised guidelines will address a host of items including increased requirements regarding comparability testing with a reference drug product as well as various ethical questions.

U.S. FDA Approves a “Similar” but not a “Biosimilar” version of Lantus®

On December 16, 2015, the U.S. Food and Drug Administration (FDA) announced that it had approved Eli Lilly/Boehringer Ingelheim’s (Lilly) Basaglar® product as the first “follow-on” insulin glargine product for use in improving glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.  Basaglar® is the first insulin product approved through an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act.  Specifically, Lilly submitted a 505(b)(2) application for Basaglar®  that relied, in part, on the FDA’s finding of safety and effectiveness of Sanofi’s Lantus® for its approval.  While similar to Lantus®, Basaglr® was not approved as a biosimilar.  In contrast, in Europe, on September 9, 2014, the European Medicines Agency approved Lilly’s product as a biosimilar under the brand name Abasaglar (originally approved under the brand name Abasria).

While Basaglar® received tentative approval from the FDA in August 2014, a 30-month hold was placed on its market entry because of a patent infringement dispute with Sanofi which was settled in September 2015.

©2020 MICHAEL BEST & FRIEDRICH LLPNational Law Review, Volume VI, Number 8


About this Author

Lisa Mueller, Michael Best, Patent application Attorney, intellectual property lawyer,
Partner, Industry Group Chair, Life Sciences

Lisa provides strategic counsel on complex patent issues to clients in the pharmaceutical, biopharmaceutical, biotechnology and chemistry sectors. She brings an in-depth knowledge and extensive experience to her work advising clients on patent protection, freedom to operate and invalidity of blockbuster drugs they aim to produce and distribute.

Lisa’s advice on the full spectrum of global intellectual property portfolio management includes patent prosecution, opposition and other post-grant proceedings