Biocon Cited for Manufacturing IssuesBy
Biocon, a Bangalore, India-based pharmaceutical manufacturer, has been cited by French regulatory authorities for GMP deficiencies in a drug-product manufacturing plant that will make pending biosimilars, including pegfilgrastim (reference product, Amgen’s Neulasta) and trastuzumab (reference product, Roche’s Herceptin). Biocon is partnered with Mylan for these and other biosimilars.
The French pharmaceutical regulatory authority, L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), notified Biocon that its drug-product manufacturing facility making trastuzumab, pegfilgrastim, and related insulin glargine (pen assembly only) products will have to be re-inspected following a pre-approval inspection at the facility. These biosimilar products are pending approval by the European Medicines Agency (EMA).
ANSM had conducted pre-approval inspections of Biocon’s drug-substance and drug-product manufacturing sites related to the pending EMA marketing authorization applications. Biocon said while there were no critical observations mentioned in the final report, ANSM notified Biocon that the receipt of a GMP compliance certificate for the drug-product facility will require a follow-up inspection from ANSM to verify implementation of the proposed corrective and preventive actions (CAPAs). ANSM has reviewed the proposed CAPA plan, and Biocon said it is progressing toward completion of the implementation of these CAPAs. Biocon said it will work its partner Mylan and French and European regulatory authorities with regard to the follow-up inspection of the drug-product facility and the marketing authorization applications with the goal of an early re-inspection.
Biocon said ANSM has issued GMP compliance certificates for its two drug-substance manufacturing facilities in Bangalore.
Biocon is partnered with Mylan for the development, manufacturing, supply, and commercialization of up to six proposed biosimilars, which includes trastuzumab, pegfilgrastim, and insulin analogs. Trastuzumab is the active ingredient in the reference product, Roche’s Herceptin, a drug for treating HER2-positive breast and gastric cancers. It had 2016 global sales of CHF 6.78 billion ($7.03 billion). Pegfilgrastim is the active ingredient in Amgen’s Neulasta, a leukocyte factor for treating neutropenia, or low white blood cell count, in patients with certain types of non-myeloid cancers. Neulasta is one of Amgen’s top-selling drugs with 2016 sales of $3.9 billion. The companies are also developing a biosimilar of Sanofi’s Lantus (insulin glargine), which had 2016 sales of EUR 5.71 billion ($6.54 billion).