Lilly/BI's Basaglar: A Rosier Outlook For US Biosimilars?
Sales of the insulin glargine product in its first full year on the market were strong at $432.1m, but Lilly said it is offering steep rebates in exchange for market access and it's not clear that the growth is sustainable if more copies enter the market.
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Biopharma manufacturers dispute predictions that passing through rebates at the point-of-sale in Medicare Part D would increase government spending. Pharmacy benefit managers argue the policy would violate the Part D statute and the Trade Secrets Act.
Short-acting insulin approved under 505(b)(2) pathway appears poised to receive three years of Hatch-Waxman exclusivity but would lose nine months of this protection under FDA's current interpretation of the 'transition provisions' for certain protein products that take effect in March 2020.
The US launch of Pfizer's Inflectra has been an early case study for the US biosimilar market, and some biosimilar manufacturers and payers say market access challenges are worrying.