The 350,000 square-foot manufacturing facility now has a capacity of 42,000 L, up from 6,000 L, providing Biocon with “significant additional capacity,” a spokesperson for Biocon told us.
The facility previously received European Medicines Agency (EMA) approval to produce its version of Roche’s Herceptin (trastuzumab), Ogivri, and now has approval to manufacture another of its biosimilars, a version of Avastin.
Bevacizumabis a monoclonal antibody (mAb) used to treat different types of cancers specifically metastatic colorectal cancer, lung cancer, and ovarian cancer. First approved as Avastin for Genentech (now Roche) by the US Food and Drug Administration (FDA) in 2004, the drug is a recombinant humanized IgG1 monoclonal antibody that binds with high affinity to human vascular endothelial growth factor.
Biocon is yet to have won marketing approval for its bevacizumab biosimilar in the EU, but has versions of it available in other markets, including Canada under the brand Abevmy, and India and Sri Lanka, under the brand Krabeva.
Additionally, following a GMP inspection, the firm renewed a certification for its facilities in Bengaluru and Malaysia. On behalf of the EMA, the certificate was issued by the Health Products Regulatory Authority (HPRA).
The 562,000 square-foot site in Johor, Malaysia is a manufacturing plant majorly dedicated to producing insulins, along with a broad portfolio of regular, basal, and rapid insulins.
Significantly, the facility has frequently faced regulatory issues in the past. In July 2019, the plant received a Form 483 with 12 observations, several of which were repeats from a pre-approval inspection carried out in February 2018.
This was followed by another Form 483 with six observations, which the plant received in September 2021, but Biocon was confident of it having no impact on its commercialization in the US. Moreover, in October 2023, the FDA hit Biocon with a Complete Response Letter (CRL) for its insulin aspart biosimilar product citing deficiencies.
“We are continuing to supply all of our existing commercial products in the US and to be engaged with the US FDA on our continuous improvement programs and providing all requested information,” the spokesperson said.
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