Biocon bets on biosimilars for global ascendancy

Biotechnology major Biocon is banking on four advanced programmes aimed at treating cancer, diabetes and psoriasis to emerge as a leading global player in the field of biosimilars, Biocon Chairperson Kiran Mazumdar-Shaw has said.
The company is bullish on the four programmes to provide it an early mover advantage in an over USD 30 billion addressable market.
"Regulatory filings for four most advanced biosimilar programmes - Insulin Glargine, Trastuzumab, Pegfilgrastim and Adalimumab - are likely to provide us an early mover advantage in an over USD 30 billion addressable market," Mazumdar-Shaw said while addressing shareholders at company's annual general meeting.

Bullish on the progress of the programmes, she added: "We are positioned among the early wave biosimilar entrants in the developed markets...We believe that the current fiscal will set the stage for Biocon to emerge as a leading global player in the realm of biosimilars".
She said Biocon has achieved a major regulatory milestone with its first biosimilar approval for Insulin Glargine in a highly regulated market like Japan.
"This we believe, earns us huge credibility and validated our mission of delivering highest quality at lowest cost. Our partner Fuji Pharma expects to launch this product soon," she said.

This also paves the way for Biocon to foray into several other overseas markets, including key ones like Brazil, Russia and South Africa.

"Currently our insulins are registered in over 65 market that represent 40 per cent of the global diabetes population. We continue to progress our efforts to take insulin glargine to key developed markets in Europe and the US with our co-development partner, Mylan. We expect to file for regulatory approvals in the EU and in the US in 2016-17 ," she said.
On cancer, Mazumdar-Shaw said: "We also commenced Trastuzumab sales in emerging markets this year and expect to take this important biosimilar drug to several more in this fiscal."
She said the company and its partner Mylan through clinical trials have established the efficacy, safety and immunogenicity of their proposed biosimilar Trastuzumab in comparison to branded Trastuzumab.

"The trial will enable regulatory filings for our product in the developed markets in 2016-17," she said.
This study met the primary endpoints of demonstrating
clinical equivalence with the reference product, putting the company on track for regulatory submissions in the US and Europe this fiscal, she said.
Overall, she said: "Regulatory approvals of our new manufacturing facilities, increased penetration of our biosimilar products and resilience in our Branded Formulations business are expected to boost our biopharma business."
Mazumdar-Shaw also said Biocon's "generic formulations business is expected to gather momentum in 2016-17 as we intensify our focus on being a vertically integrated player in the niche space of difficult-to-make and technologically intensive generic drugs".