This approval will provide significant additional capacity to address patients’ needs across markets in Europe. The facility has previously been approved to manufacture biosimilar Trastuzumab in September 2022.

The company further informed that the EMA has renewed its good manufacturing practice (GMP) certificates of compliance for its biosimilars manufacturing facility at Bengaluru and its insulin facility in Malaysia following routine GMP inspections. These certificates were issued by the Health Products Regulatory Authority (HPRA), Ireland, on behalf of EMA.

"These GMP certifications across our manufacturing sites in India and Malaysia reflect Biocon Biologics’ continued compliance with the highest standards of quality and our unwavering commitment to addressing patient needs globally,” Biocon’s spokesperson said in a statement.

Biocon is an innovation led global biopharmaceuticals company, engaged in the production of therapies for chronic conditions like diabetes, cancer and autoimmune.

It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development.

The company had reported 56.74% decline in consolidated net profit to Rs 135.5 crore despite of 3.79% rise in revenue from operations to Rs 3,917.1 crore in Q4 FY24 over Q4 FY23.

The scrip shed 0.67% to currently trade at Rs 343.30 on the BSE.