Biocon sees growth from new markets, no risk from USFDA biosimilar norms

Biocon expects continued growth momentum in its insulin and biosimilar business and sees no significant risks to its product approvals in the US due to the proposed guidelines in that country.

Biocon posted 65 per cent growth in net profit to Rs 171 crore in Q3FY17 on a year-on-year basis, driven by 32 per cent growth in revenue. The biologics segment was the main contributor to revenue and grew 61 per cent y-o-y. The company said it did not face a significant impact due to demonetisation though its branded formulation sales in India were affected.

"We expect our biologics business to continue on its strong growth trajectory as we ramp up sales of our generic insulins and biosimilar monoclonal antibodies through deeper penetration in existing markets and opening new markets in the medium term. The commercialisation of the Malaysia plant is expected to augment our capacities which will enable us to address growing patient needs globally," said Arun Chandavarkar, CEO of Biocon.

Chandavarkar feels that the proposed USFDA guidelines on interchangeability of biosimilars will not impact the company's approvals. The company jointly with drug maker Mylan has submitted an application for biosimilar Trastazumab. In Europe the two companies have made three biosimilar product filings.

According to analysts the draft guidelines issued last week are stringent and are expected to lengthen the product approval process.

"The draft interchangeability guidelines are on the expected lines and are yet to be finalised hence its too early to comment on the impact. The guidelines pertain to interchangeability which means whether the biosimilar can be substituted for an original biologic drug at the formulary. We believe the initial set of filings would not be impacted by the guidelines, also the impact will be on a product-to-product basis. Our initial view is that this should not impact our approvals," he said.

"We are on track for commissioning our potent oral dosage manufacturing plant in Bengaluru in first half of FY18. This will be our first plant for manufacturing oral solid dosages and will support our pipeline of new products," Chandavarkar added.