The regulatory filing - containing data showing the long-acting insulin analog’s is bioequivalent to Sanofi’s Lantus - was accepted by the European Medicines Agency (EMA), Biocon announced yesterday.
“The product filed in EU has been co-developed by Biocon and Mylan for developed markets,” a Biocon spokesperson told this publication. “This filing of Insulin Glargine in EU is the first filing in a developed market that incorporates product validated at our new state-of-the-art integrated Insulins Manufacturing facility in Malaysia.”
The facility in Malaysia was commissioned in 2015, and is now qualified for commercial sales of rh-insulin in the local Malaysian market.
“Regulatory filings for a couple of emerging markets are underway to enable commercial sales from the Malaysian facility,” we were told, and “from a capacity perspective, we are well-placed to cater to our mid-term demand in both emerging and developed markets.”
If accepted, the product will be marketed in the EU by Mylan, under terms of a co-development partnership which also incorporates six biosimilar mAbs and recombinant proteins - trastuzumab, adalimumab, bevacizumab, pegfilgrastim, etanercept and filgrastim. The firms are also co-developing three insulin analogs - glargine, lispro and aspart.
If approved, the product would become the second Lantus biosimilar in Europe following Eli Lilly and Boehringer-Ingelheim’s Abasaglar which was given the thumbs up in 2014 (at the time under the name Abasria).
Eli Lilly/B-I’s product is also approved in the US under the brand name Basaglar, though as a new chemical entity rather than a biosimilar.
According to Biocon, there are plans to file Mylan and Biocon’s insulin glargine in the US in fiscal year 2017.
“We can’t provide specific details on the timing of our subsequent regulatory filings, but we are confident of being among the first wave of biosimilars players to enter the developed markets of EU and US.”
UPDATE - Lilly and Boehringer Ingelheim’s insulin glargin was approved in the EU under the name Abasria, but Eli Lilly contacted us to clarify that the trade name was updated in the European Union to ‘Abasaglar.’
"Although ‘Abasria’ was an approved name in Europe, ‘Abasaglar’ allows Lilly and Boehringer Ingelheim to have a common or alike trade name for the Alliance’s insulin glargine product across many parts of the world," we were told.