Biocon, the first Indian company to have a biosimilar drug approved in the US, is taking another step forward with a new manufacturing facility and an expansion into the Australia and New Zealand markets.
We see ourselves as a company that has great capabilities and is investing big time in not just expanding these capabilities but also expanding our focus on innovation and on building global scale in our operations.
Indian biotech giant Biocon is further expanding its biosimilar offerings with a newly licensed FDA-approved manufacturing facility and a strategic decision to commercialise in Australia and New Zealand. Biocon amended an originally exclusive licensing agreement with US-based biotech Equillium to develop and commercialise its novel anti-CD6 monoclonal antibody itolizumab, allowing Australia and New Zealand to be included.
After undergoing a pre-approval inspection by the US FDA in September 2019, Biocon Biologics, a subsidiary of Biocon and Mylan, was given the green light to begin manufacturing Fulphila (pegfilgrastim) at its Bengaluru facility in India. The new facility will enable the company to scale up capacity and expand its offerings in the US and other global markets. Fulphila, a knockoff of Amgen’s Neulasta, was the first biosimilar pegfilgrastim to be FDA approved, commercially launched in July of 2018 in one of the most successful biosimilar launches in the US. The drug is a blood cell booster used to prevent infection during cancer treatment.
It hasn’t always been smooth sailing for Biocon, which had previously come up short in inspections for various issues, including sterilizing procedures, labelling and validation. Changes made at the Fulphila facilities led the FDA to issue a complete response letter. Furthermore, according to author Shweta Punj, during the company’s humble beginnings in 1978, founder Kiran Mazumdar-Shaw faced surmounting challenges with their roots in gender discrimination: employees didn’t want to work for a woman and investors were wary of investing in a female-led company. (Source)
Despite setbacks Biocon has forged ahead, establishing partnerships with some of the world’s leading multinational companies, such as Bayer, Novartis, and BMS. In the last two years the company has also celebrated the US FDA approval of Ogivri™, the first biosimilar for trastuzumab, and the Japanese regulatory agency PMDA’s approval of Biocon and Mylan’s insulin biosimilar glargine. Biocon’s four decades of success have landed Ms. Mazumdar-Shaw a number of awards, including appearing on Forbes’ Power Women 2019, India’s Richest 2019 and Billionaires 2019 lists.
Speaking about the decade-long partnership between Biocon and Mylan in an interview with PharmaBoardroom, Mazumdar-Shaw stated that the two companies “…have always had a strategic partnership in the space of biosimilars and we recognized this opportunity in 2009. Even at that time, I think both companies recognized that this was going to be a huge need and a huge opportunity. Mylan recognized that biosimilars was going to drive growth for them and for us it was certainly a very important business strategy with which we could grow. We entered this partnership to develop a diverse portfolio of products, where Mylan, because of its stronger commercial profile, would actually lead the commercial side of the partnership in the US and the EU. So far, it has worked out very well for both partners and I do believe that this partnership that will deliver good returns for both parties.” She continued to elaborate on Biocon’s global vision, “We see ourselves as a company that has great capabilities and is investing big time in not just expanding these capabilities but also expanding our focus on innovation and on building global scale in our operations.”