Biocon Hopes To Grab ‘Major’ Share Of $3-Billion Trastuzumab Market In U.S.: Kiran Mazumdar-Shaw

Biocon Ltd. hopes to make a “major impact” in the $3-billion market for Trastuzumab biosimilar in the U.S., Chairman and Managing Director Kiran Mazumdar-Shaw said a day after the drug’s launch.

“The U.S. stamp of approval itself offers us a larger global opportunity. What’s also important for us is the U.S. market which will not have too many competitors. This makes it a very attractive and important market opportunity,” she told BloombergQuint in an interview.

Biocon is the second drugmaker to launch the breast cancer drug in the U.S. despite being the first to receive approval from the country’s drug regulator. Amgen was the first company to launch the drug “at risk”—or while patent litigation is ongoing—in July 2019. Celltrion-Teva, Samsung and Pfizer also have the approval but are yet to launch the drug.

Biocon has launched the drug with Mylan NV under the brand name Ogivir in both 420mg and 150mg formulations. The Indian firm has a 33 percent profit share in its deal, with Mylan responsible for the commercial side of it.

According to Citi, Ogivir has an edge over Amgen’s Kajinti on two counts—Kajinti was launched “at risk”, and Ogivir comes in two formulations compared with Kajinti’s single 420mg formulation. The 150mg formulation is preferred in the U.S., Shaw said.

WATCH | Biocon’s Kiran Mazumdar Shaw on scope of Trastuzumab biosimilar in the U.S.

Brokerage Views On Biocon

BofA Securities

• Forecast 5 percent share for Mylan in bHerceptin market in calendar year 2020 at average price discount of 45 percent.
• Ogivri launch plus expanded capacity in bNeulasta bodes well for biosimilar sales.
• Catalyst in possible clearance of Malaysia plant and approval of bLantus by March 2020.

Citi

• Biocon/Mylan have an edge on two counts, i) it has a settlement with the innovator whereas Amgen’s launch is an “at risk”; ii) Ogivri is available in both strengths (150 mg and 420mg) whereas Kajinti is available only in the 420mg form.
• Estimate $19/56/67 million revenue upside for Biocon from Ogivri in Financial year 2020/21/22.

Goldman Sachs

• Third-party data suggests that Mylan has priced Ogivri at a discount.
• bHerceptin in the U.S. will contribute around 8 percent to Biocon’s FY21 earnings per share estimates.
• In bullish case, could see 3 percent to 17 percent further accretion potential to Biocon’s FY21 profit after tax.
• Build in an around 10 percent share for Biocon in bHerceptin syringes in the U.S. market for FY21.

HSBC

• Raise target price to Rs 325 from Rs 280, maintain ‘Buy’.
• Lift our FY20/21/22 EPS estimates by 7.7/13.1/18.2 percent.
• Biocon remains well placed to gain from a favourable push for biosimilars.
  

Morgan Stanley

• Biocon/Mylan could generate $180- 220 million in sales at high margins in 1-2 years.
• bGlargine is the next potential U.S. biosimilar launch by Biocon, by end of March 2020.