MOSL: BIOCON (Neutral)-Positive Committee opinion-However, launch subject to multiple factors
BIOCON: Positive Committee opinion; However, launch subject to multiple factors
(BIOS IN, Mkt Cap USD5.4b, CMP INR658, TP INR625, 5% Downside, Neutral)
- The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval for Biocon (BIOS)/Mylan's Herceptin (Trastuzumab) biosimilar. This is one of the major considerations by European Commission for approval.
- We note that four more companies have also received a positive opinion from CHMP and three got approval from EMA. Out of those, two have launched as well.
- In addition, there is settlement in place between Mylan and Roche (innovator) for launch. Considering existing competition, more filers in the offing, profit sharing agreement between Mylan and BIOS, there are considerable dynamics to play out before launch.
- Given the favorable regulatory pathway emerging for biosimilars in the US/EU markets and the significant untapped market potential, we believe that biosimilars prospects remain very promising from a 4-5 year perspective. BIOS also stands to benefit from its improved traction in approved products and healthy pipeline of pending approvals.
Biocon is an Indian biopharmaceutical company. Through its subsidiaries, Co. manufactures biotechnology products and is engaged in research and development in biotechnology. Co. provides a range of products from fermentation derived small molecules to recombinant proteins and antibodies. It has developed and taken a range of novel biologics, biosimilars, differentiated small molecules and recombinant human insulin and analogs from 'Lab to Market'. In research services, Co., through Syngene International Limited, is engaged in the business of custom research in drug discovery while the other subsidiary Clinigene International Limited (Clinigene) is engaged in clinical development.
Motilal Oswal Financial Services Ltd. is a reputed name in Financial Services and Online Trading with group companies providing services such as Private Wealth Management, Retail Broking and Distribution, Institutional Broking, Asset Management, Investment Banking, Private Equity, Commodity Broking, Currency Broking, Principal Strategies & Home Finance.
Motilal Oswal Securities is a group company of Motilal Oswal Financial Service Limited which started as a stock trading company and has blossomed into well diversified firm offering a range of financial products and services. Motilal Oswal has built a reputation as the source for best stock trading company and this has taken a wealth of experience, knowledge and expertise, constantly working in tandem, over the years.
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