Mylan and Biocon Neulasta biosimilar knocked back by FDA

Mylan and Biocon’s biosimilar version of Amgen’s blockbuster, Neulasta (pegfilgrastim), will have to wait a bit longer before getting the nod from the FDA, after receiving a CRL related manufacturing plant issues. In reality, it shouldn’t be more than a hiccup for the partnership, with Biocon stating that it shouldn’t change the commercialisation timeframe.

The reason for the CRL is actually in response to a previous red light given by the FDA, in relation to the partnership’s biosimilar for Herceptin. This biosimilar also received a CRL due to criticisms of the processes at the Bangalore plant, this led Biocon to overhaul its CMC processes and the FDA suggested that it needed the updated CMC data regarding the Neulasta biosimilar to proceed.

Biocon revealed the CRL and made the following statement: "The CRL relates to the pending update of the BLA with certain CMC data from facility requalification activities post recent plant modifications. The CRL did not raise any questions on biosimilarity, pharmacokinetic/pharmacodynamic data, clinical data or immunogenicity.

"We do not expect this CRL to impact the commercial launch timing of biosimilar pegfilgrastim in the US. We are committed to working with the agency to resolve the issues stated in the CRL expeditiously."

The FDA has decision date for the Neulasta biosimilar of 2 December so the indication that commercialisation timeline would not be affected suggests that Biocon is confident that it can qualify its new data with the FDA without any issues.

This perhaps goes someway to explain the unusual situation of shares in Biocon actually rising 5% on the announcement that it had received a CRL.

For Amgen, it represents a slightly reprieve from fears of an immediate biosimilar rival to Neulasta. The product brought in $1.1 billion in global sales last quarter and represents over 20% of total sales for the company.

However damaging biosimilars to its own products are, Amgen is fighting back with biosimilars for its rivals’ drugs – agreeing a deal with AbbVie to bring its Humira biosimilar to market in Europe next year.