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Mylan looks to biosimilars for long-term growth as Viatris deal closure nears

Reporting earnings for the final time before becoming Viatris, Mylan Inc. sees the company's global biosimilar franchise as one of its "key long-term growth opportunities," President and Executive Director Rajiv Malik said on a second quarter earnings call.

Mylan's overall portfolio, which includes a range of biosimilar drugs and generics, allowed the company to absorb a negative revenue impact due to COVID-19 of 2% during the first half of 2020, Malik said.

CEO Heather Bresch noted that the pandemic recovery efforts are slower than expected and may last till the end of the year. She expects the second half to have an overall similar negative revenue impact of 2%.

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Mylan CEO Heather Bresch said pandemic recovery efforts have been slower than expected.

Source: Mylan

Mylan will join with Pfizer Inc.'s generics and off-patent drugs unit Upjohn Inc. to become Viatris, with only a few regulatory approvals needed to complete the deal, Chairman Robert Coury said. The deal is set to close in the fourth quarter.

Bresch echoed comments from Teva Pharmaceutical Industries Ltd. CEO Kåre Schultz criticizing recent executive orders from President Donald Trump that seek to boost manufacturing of essential pharmaceutical ingredients in the U.S.

"It needs to be sustainable and not political. I think that certainly we would participate in something that is over the longer-term and sustainable for the U.S.," Bresch said.

She noted the pharmaceutical industry has always been subject to the Buy American Act of 1933 that has actually disincentivized manufacturing in the country.

"There would need to be very significant structural changes into the market dynamics and pricing in the U.S. healthcare system to incentivize [active pharmaceutical ingredients] and/or drug manufacturing in this country," Bresch said.

Focus on biosimilars

With the deal progressing, the company is focusing on expanding the biosimilar franchise in Europe with the launch of Nepexto in August. The European Commission granted approval for the biosimilar version of Amgen Inc.'s autoimmune drug Enbrel in June. A biosimilar is a biological product developed to be highly similar to an already-approved reference product.

Mylan is also focused on adding a Botox biosimilar to its portfolio and is conducting preclinical trials in collaboration with Revance Therapeutics Inc. with the FDA's agreement on the clinical program.

"Our goal is to bring this product to the market by 2025," Malik said.

The U.K.-based company's net sales in Europe during the first half were up 7% on an annual basis and amounted to $2 billion. Mylan focused investments in selling and marketing that resulted in strong growth in various brands in the region, including Hulio, Malik noted.

Anti-inflammation drug Hulio is a biosimilar of AbbVie Inc.'s best selling drug Humira. Mylan acquired rights to commercialize the drug in Europe from Fujifilm Kyowa Kirin Biologics Co. Ltd. in 2018 but will have to wait until July 2023 to launch in the U.S. due to an agreement with AbbVie. Hulio was approved by the U.S. Food and Drug Administration in July.

Malik said that Semglee — a biosimilar of Sanofi's blood sugar control drug Lantus that was approved by the FDA in June — will be launched in the U.S. in the coming weeks. Semglee was co-developed by Mylan and Indian biotechnology company Biocon Ltd.

The two companies also worked together to develop MYL-1402O, a biosimilar of Roche Holding AG's blockbuster cancer therapy Avastin. The application for approval is under review by the FDA and Mylan expects to receive a decision by the end of 2020.

A tentative approval from the FDA is expected by the end of the year for a generic version of AstraZeneca PLC's Symbicort inhalation aerosol product, which is used to treat asthma and chronic obstructive pulmonary disease, or COPD. The 30-month stay date, because of a patent infringement lawsuit between the companies, is March 2021, and the FDA cannot give complete approval during the stay period.

Mylan saw minimal COVID-19 impact in the North American region during the first half. Net sales in the territory during the first six months were $2 billion, with generic medicines Wixela and Yupelri being the main revenue drivers.

Yupelri, or revefenacin, which is used for the treatment of patients with COPD, grew more than 600% on an annual basis in the first half of the year, Chief Commercial Officer Anthony Mauro said on the call.

As for the Viatris deal, Coury said the new management team will provide opening guidance for full-year 2021 with fourth quarter earnings. The chairman envisions the new company as a secondary source that all countries are going to need despite the overall inward focus.

"I do see a potential upside opportunity just like we were approached on remdesivir, hydrochloric or any other needs that I see arise in the world, and it's not just limited in the U.S.," Coury said.