By Corporate Communications Team

Biocon reported results for the second quarter and first half of FY17 on Thursday. While our performance in the quarter was led by strong growth across Small Molecules, Biologics and Research Services businesses, it was a stand-out quarter for the Biologics business.

Our Biologics vertical comprises a rich portfolio of novel biologics and biosimilars. We have among the largest and most diversified portfolios of biosimilars, spanning generic insulin and insulin analogs, monoclonal antibodies and other recombinant proteins.  Increased sales of key products in some emerging markets were the driver for the 26% year-on-year sales growth in the Biologics business in the quarter and 48% growth in the first half.

As a company committed to addressing challenges associated with non-communicable diseases, Biocon is developing affordable biopharmaceuticals for diabetes, cancer and autoimmune diseases. We are a pioneer in bringing the benefit of high quality, yet affordable, biosimilars or follow-on biologics such as recombinant human insulin and Insulin Glargine to patients in India and other emerging markets. We are now looking to extend the benefits of our low-cost, high-quality products to a global patient population. To take our biosimilars to a larger patient pool, we have partnered with US-based Mylan for the co-development of a high-value portfolio of six biosimilars for cancer and autoimmune indications – Trastuzumab, Pegfilgrastim, Adalimumab, Bevacizumab, Etanercept and Filgrastim – and three generic insulin analogs – Glargine, Lispro and Aspart.



In the second quarter, we filed with the European Medicines Agency (EMA) for regulatory approval to sell our proposed biosimilar Trastuzumab to treat certain aggressive forms of breast and gastric cancers. This was our second regulatory submission in EU. Earlier this fiscal, we had sought the EMA’s approval to sell a proposed biosimilar Pegfilgrastim. Pegfilgrastim is prescribed for cancer patients to help them with some of the side-effects of their treatment. It reduces the duration of neutropenia (low levels of neutrophils, a type of white blood cell that fights infections) and the incidence of febrile neutropenia (neutropenia with fever) that are a result of their chemotherapy treatment. The EMA’s approval to sell biosimilar Pegfilgrastim will enable enhanced access to a cost-effective alternative for patients undergoing chemotherapy in the EU.

These regulatory submissions with the EMA mark significant milestones in our journey to develop affordable biologics for patients in developed markets. We are on track for four regulatory filings of our biosimilars in developed markets in the current fiscal year.



What provides us confidence in terms of approvals for our biosimilars in developed markets is the quality of our clinical trials data. We presented positive results of two pivotal Pegfilgrastim biosimilar studies at the prestigious European Society of Medical Oncology (ESMO) Annual Congress at Copenhagen, Denmark during the quarter. We also presented positive 48-week data from the global Phase III clinical trials for our proposed biosimilar Trastuzumab at ESMO.



Biocon obtained its first biosimilar approval in a developed country when Japan, which has a reputation of very high expectations of product quality and manufacturing standards, approved sales of our Insulin Glargine in the country through our partner FUJIFILM Pharma. Biocon’s Insulin Glargine, a long-acting insulin analog, is the first biosimilar from India to be launched in Japan. Our ready-to-use, disposable Insulin Glargine pen has been well received and is likely to make significant inroads in Japan. The significance of the Japanese approval for Glargine goes beyond Japan as it will likely open some markets for us that rely on a developed country approval and provides confidence in terms of approvals in other developed markets.



While our global scale capacities for manufacturing high quality, affordable biologics have positioned us as the world’s fourth largest insulins producer, Biocon has invested US$200 million to set up an integrated insulin manufacturing facility in Malaysia, one of the largest in Asia, to address the growing needs of diabetes patients across the globe. Regulatory filings are underway to enable commercial sales from the new facility to some of the emerging markets initially and developed markets later. We are on track for the commercialization of the facility later this fiscal, which will enable us to cater to the growing demand for affordable insulins in both emerging and developed markets.

Biocon’s rh-Insulin is the first product manufactured at Malaysia to be approved for commercialization by the Ministry of Health, Malaysia. In fact, our rh-insulin, which is registered in over 60 emerging markets, is being sold in several of these markets through our partners. Our Insulin Glargine is registered in over 20 emerging markets.



We have also made significant progress with Trastuzumab sales and licensing in some of the key emerging markets of Africa & Middle East and Latin America regions in the quarter, which augurs well for this business.

We expect to build on the strong momentum in the Biologics business in the second half of this fiscal as we ramp up sales through deeper penetration in existing markets and entry into new markets.




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