FDA Approves Biocon's New Facility in Bangalore for Production of Fulphila® (Pegfilgrastim)

VCBeat (WeChat ID:vcbeat) learned that,2019Year11Month27Daily, BioPharmaceuticalsCompanyBioconAnnounced the U.S. Food and Drug Administration (FDA) has approved the production of pegfilgrastim at its new facility in BengaluruNeulasta（pegfilgrastim) biosimilarsFulphila®。

Fulphila®, co-developed by Biocon and Mylan, is its first biosimilar pegfilgrastim approved in the United States, commercially launched in July 2018. It is one of the most successful biosimilars in the U.S. and has currently been approved in other developed markets, including the European Union, Australia, and Canada.

It is reported that the FDA conducted a pre-approval inspection of this new drug manufacturing facility from September 10 to September 19, 2019.

Biocon is an innovation-led global biopharmaceutical company committed to providing affordable access to complex therapies for diabetes, cancer, and chronic autoimmune diseases. The company is a global developer of high-quality biosimilars, including statins, immunosuppressants, and specialty molecules. Biocon has developed novel biologics, biosimilars, and complex small-molecule active pharmaceutical ingredients (APIs) in India and several key global markets, and has commercialized these drugs in the United States and Europe.

Mylan is a global pharmaceutical company dedicated to setting new standards in healthcare and providing high-quality medicines to 7 billion people. The company offers more than 7,500 products, including prescription drugs, branded generics, biosimilars, and over-the-counter (OTC) medications.

In a press release, Biocon stated that the FDA’s approval of its new drug manufacturing facility in Bengaluru for Fulphila® will help its subsidiary, Biocon Biologics, and its partner Mylan to exponentially expand production capacity to meet demand in the United States and other global markets.

Christiane Hamacher, CEO of Biocon Biologics, stated, “We are delighted to see the FDA approve the manufacturing license for our biosimilar, pegfilgrastim, which is produced at our new biologics facility. This approval marks a significant milestone in our 22-year history of serving 5 million patients and achieving $1 billion in revenue. It will enable us to better meet global patient demand for Fulphila®.”

She added, “The continued adoption of biosimilars will generate further cost savings for the U.S. healthcare system, thereby enabling patients to access high-quality, affordable biologic therapies. We are committed to leveraging our scientific and technological capabilities, manufacturing scale, and expertise to expand global patient access to biosimilars such as pegfilgrastim.”

(Compiled by Xiong Hui)