19 October 2018 No. 3927 Scripscrip.pharmaintelligence.informa.com Pharma intelligence | informa The follow-on product, developed with partner Samsung Bioepis Co. Ltd., would have been the third Lantus version on the market in the US behind Sanofi’s original product and Eli Lilly & Co.’s Basaglar, which launched in December 2015 after Lilly reached a patent settlement agreement with Sanofi. Both copies are technically approved under the 505(b)(2) regulatory pathway for NDAs, rather than through the biosimilar pathway, based on the way insulin is cate- gorized at the FDA, but the agency is recat- egorizing insulins as biologics in a transition that will go into effect in 2020. ANOTHER SETBACK FOR BIOSIMILARS? Merck’s decision could be another sign that the US biosimilar market isn’t living up to the early hype. A handful of initial lackluster Merck Exits Insulin Glargine Market, launches have raised questions about the commercial potential for biosimilars in the US in the near-term. Even FDA Commis- Remains Committed To Biosimilars sioner Scott Gottlieb has expressed concern JESSICA MERRILL
[email protected] that slow launches could lead drug manu- facturers to curtail biosimilar R&D. (Also see erck & Co. Inc. has decided that The decision is surprising since the prod- “FDA’s Gottlieb: ‘Pricing And Reimbursement it will not commercialize its own uct was tentatively approved by the FDA in Mischief’ Holding Back Biosimilar Market” - Mversion of Sanofi’s Lantus (insulin July 2017, though it had not launched. Ten- Scrip, 7 Mar, 2018.) glargine) in the US, even though the prod- tative approval is used by the FDA when a Momenta announced Oct.