Trending Large cap stocks: Biocon seeks approval for its Breast Cancer drug

Biocon shares are expected to surge after the meeting of ADCOM (US drug regulator’s Advisory Committee) due to higher chances of positive outcomes from the same.

This meeting would be held today for the discussion of filing for Trastuzumab by Mylan, Biocon’s Partner.

Trastuzumab is used in the treatment of metastatic breast cancer.And it is also effective for tumours.

The stock has witnessed a downtrend in recent times after the ANSM (French National Agency for Medicines and Health Products Safety) inspection on behalf of EMA (European Medicine Agency) and found issues in GMP (Good Manufacturing Practices) at Bengaluru facility for 3 biosimilar products.

If the agency approves the drug then Biocon will be benefited as it will be the first player, to introduce Herceptin Biosimilar in the US market.

In the last fiscal Roche’s Herceptin has generated sales of USD 7 billion approximately which is expected to lose its exclusivity in 2019.

As FDA’s view on clinical data in its briefing document is favourable, there are higher expectation of positive recommendations coming up today by advisory committee.

After this, for BLA (Biologics License Application) approval, the agency will consider Good Manufacturing Practice (GMP) clearance with wider data submission, for Bengaluru site. This approval will also help Biocon in getting marketing approvals in few emerging markets for its biosimilar products.