Biocon says it expects US approval of its follow-on insulin glargine referencing Lantus by March 2020 despite a Sanofi lawsuit and manufacturing concerns.
In June 2018, Indian drugmaker Biocon acknowledged a complete response letter (CRL) from the US Food and Drug Administration (FDA) for its insulin glargine product, submitted under the 505(b)(2) ‘follow-on’ regulatory pathway. The product has received approval in Europe and other regions as a biosimilar to Sanofi’s Lantus, under the name Semglee.
At the time, a spokesperson said Biocon agreed “to provide additional clinical data in support of the manufacturing site change from Bangalore to Malaysia,” adding the CRL was anticipated, and built into its US approval plan.
This was reiterated in Biocon’s third quarter FY19 financial call with CEO Arun Chandavarkar telling stakeholders: “we are on track in terms of bridging the manufacturing site from Bangalore [India] to Malaysia,” and “[with regards to] the information requested by the FDA, we are on track in terms of developing and timing of submitting that data.”
The FDA inspected the Malaysian facility in February 2018 and issued a Form 483 with six observations.
The arrival of the follow-on insulin has also been delayed by a Sanofi lawsuit filed in October 2017 against Biocon’s partner Mylan alleging the infringement of 18 patents. The suit triggered an automatic stay of 30 months, thus Chandavarkar said the firm is prepared for a launch from March 2020.
“So we are tracking [the lawsuit], and we have been working with the FDA under their agreed guidance,” he said. “Our bridging studies are tracking to finish in time so that we can be in time as soon as be 30-month stay is over.
For the quarter, Biocon reported a year-on-year 43% increase in its revenues to INR 15.6 billion ($220 million). The year-to-date earnings have more than doubled, and this was attributed to the firm’s biologics segment which, for in Q3, grew 136% year-on-year.
Highlights in the sector included the growing momentum of Fulphila, a version of Amgen’s Neulasta (pegfilgrastim), launched by marketing partner Mylan earlier this year, as well as the European launch of the firm’s Humira (adalimumab) biosimilar, in-licensed from Fujifilm Kyowa Kirin Biologics.