Basaglar was tentatively given the thumbs up by the US Food and Drug Administration (FDA) in August 2014, but it was dependent upon resolving patent litigation with makers of fellow insulin glargine Lantus, Sanofi.
But Eli Lilly has now announced a settlement agreement with the French Pharma firm and final approval has been granted for the product which will be available in the US from December next year.
To BE or not to BE?
Basaglar has an amino acid sequence identical to Lantus and in Europe was approved by the EMA as the first insulin biosimilar under the brand name Abasria in 2014.
However, in the US the product has been deemed a Lantus ‘follow-on,’ neither a biosimilar nor a generic but a branded biopharmaceutical in its own right, Boehringer-Ingelheim told this publication.
“Lantus had been approved by the FDA [in 2000] not as a biopharmaceutical but as a new chemical entity (NCE),” spokesman Ralph Warsinsky said. “Therefore the approval process for our product with Lilly could not follow the US biosimilars-specific 351(k) pathway but rather the 505(b)(2) pathway.”
The pathway provides a shorter and less costly drug development programme for modified versions of a previously approved product and requires additional clinical and nonclinical studies - other than bioavailability (BA) or bioequivalence (BE) studies - to demonstrate safety and efficacy.
Earlier this year, the first actual biosimilar product – Sandoz’s Zarxio – was launched in the US but despite being heralded as a new era for biological products there remains unanswered questions regarding interchangeability of such drugs.
And equally, Warsinsky said, Lilly and Boehringer-Ingelheim still await answers as to the potential substitution by physicians and/or pharmacists of Lantus for Basaglar, though at least the insulin product does not suffer from a lack of clarity in the labelling of biosimilars which industry continues to debate, he added.
Basaglar is one of a number of products being co-developed between Lilly and B-I, and is being fully manufactured from Lilly’s Indianapolis, Indiana, plant.
“[Lilly] has long standing expertise in insulin glargine manufacturing,” Warsinsky said. “Therefore it makes sense for Lilly to make it.”
Trajenta (linagliptin), an inhibitor of the enzyme DPP4 (dipeptidyl peptidase-4), and sodium glucose co-transporter 2 (SGLT2) inhibitor Jardiance (empagliflozin) – the venture’s two other marketed diabetes franchise drugs – are made by Boehringer-Ingelheim from its facility in Germany.