FDA Rejects Mylan and Biocon's Follow-On Insulin Glargine

Mylan and its partner Biocon have received a Complete Response Letter (CRL) from the FDA in regard to their application for a follow-on insulin glargine referencing Lantus.

Though neither Mylan nor Biocon have issued corporate statements concerning the CRL, Julie Knell, senior director of global product communications for Mylan, acknowledged the CRL in an email to The Center for Biosimilars^®, and said that, “Following submission of our Insulin Glargine application under the 505(b)(2) regulatory pathway, we had agreed with FDA to provide additional clinical data in support of the manufacturing site change from Bangalore to Malaysia. Hence, the recent CRL was anticipated and built into our plan."

Knell continued, “Together, Mylan and Biocon are already executing on all required activities we had agreed upon with FDA, and they are progressing according to plan,” and said that the companies did not anticipate a change of timing for their anticipated launch.

The CRL comes after Biocon received a Form 483 from the FDA in February that noted 6 observations after an inspection of a manufacturing facility in Malaysia revealed conditions that may have violated the Food Drug and Cosmetic Act.

In contrast with the FDA's concerns, regulatory agencies in Europe and Australia have both authorized the drug. In March 2018, the product was authorized for marketing as a biosimilar by both the European Commission, following a positive opinion from the Committee for Medicinal Products for Human Use in January 2018, as well as by the Therapeutic Goods Administration of Australia. The biosimilar will be sold under the brand name Semglee in a 100 IU/mL 3mL prefilled pen in both territories.

This CRL is the latest in a series from the FDA for proposed follow-on and biosimilar products. In the last 2 months, Amgen received a CRL for its proposed trastuzumab biosimilar, ABP 980; Pfizer received a CRL for its proposed trastuzumab biosimilar, PF-05280014; and Celltrion received CRLs for its proposed rituximab and trastuzumab biosimilars CT-P10, and CT-P6, respectively.