Eye on Pharma: Biocon Receives EU GMP Certification

The Center for Biosimilars Staff

Biocon’s biologics facilities in Bengaluru, India, have received an EU certification of good manufacturing practice (GMP) after a March 2019 inspection, said the drug maker last week in a notice to the National Stock Exchange of India.

Biocon’s biologics facilities in Bengaluru, India, have received an EU certification of good manufacturing practice (GMP) after a March 2019 inspection, said the drug maker last week in a notice to the National Stock Exchange of India.

A company spokesperson said in an email to The Center for Biosimilars® that “This was a surveillance inspection of our existing [drug product, DP] and [drug substance] facilities and a preapproval inspection of our additional DP manufacturing line. This certification will enable us to continue addressing the growing needs of patients in the EU markets and enhance access to our high-quality biosimilars.”

The Bengaluru facility is the site where Biocon manufactures its portfolio of biosimilar products, including the biosimilar products on which the company partners with fellow drug maker Mylan. The partnership is responsible for such FDA-approved biosimilars as Fulphila, a pegfilgrastim biosimilar that is already available in the US market, and Ogivri, a trastuzumab biosimilar expected to launch in 2019.

The Biocon and Mylan partnership also includes in-licensed adalimumab and etanercept products in the European marketplace, as well as several insulin biosimilars in various stages of development.

Biocon has also entered into a partnership with another biosimilar developer, Sandoz, for the development, manufacture, and commercialization of multiple, as yet undisclosed biosimilars targeting immunology and oncology indications.