MOSL: BIOCON (Neutral)- Mylan/ Biocon received Trastuzumab approval in US
​Biocon: Mylan/ Biocon received Trastuzumab approval in US
(BIOS IN, Mkt Cap USD4.1b, CMP INR447, TP INR485, 9% Upside, Neutral)
- Mylan/ Biocon announced on Friday that US FDA approved Mylan’s Ogivr (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab), co-developed with Biocon. Ogivri™ is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon’s joint portfolio approved in the US. Notably, Mylan is the only player which has settled for a launch date with innovator Roche. Mylan anticipates to be the first player to launch biosimilar version of Herceptin. Patent for Herceptin is expiring in mid-2019. Since Biocon has not filed this product through interchangeable route, it will not receive exclusivity period for this product. We expect Mylan/ Biocon to launch Ogivri at least 3-6 months before patent expiry.
- Biosimilar- USD900m-1b opportunity in medium term: Trastuzumab, PegFilgrastim and Insulin Glargine could be USD1b opportunity for Mylan/ Bioocon in medium term (USD250m from each product in US/ EU and USD250m from all three products in EMs). Biocon’s sales could be ~40% of the joint portfolio with EBITDA margin of ~30%.
- Trastuzumab opportunity: Roche is generating sales of ~USD2-2.5b/USD2b and ~USD1.8b from US, EU and EMs, respectively. Pfizer, Amgen/ allergen and Teva/ Celtrion have also filed BLA in 2H CY17 with US FDA. Hanwha, and Samsung are other potential late stage filers. Biocon has re-filed Trastuzumab and PegFilgrastim with EU regulator in 3Q FY18.
- PegFilgrastim opportunity: Pegfilgrastim is a USD4.5b opportunity with US sales of ~USD3.7-3.8b. Because of multiple biosimilar players in EU region for Filgrastim, market size of Pegfilgrastim has come down to ~USD500m. Apotex, Coherus, Sandoz and Cinfa are other late stage filers for this product. Apotex has partnered with Intas for manufacturing supply and Intas’ plant has received 483s in mid-2017. Coherus received CRL from US FDA in Jun-17 and is expected to re-file the product in next 1-2 quarters. Sandoz will be re-filing the product in 2019. Biocon is planning to re-file the product in next few months.
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.
Unfortunately, this report is not available for the investor type or country you selected.
Browse all ResearchPool reportsReport is subscription only.
Thank you, your report is ready.
Thank you, your report is ready.