Manufacturing Roche relying on Polivy's $2B potential to weather biosimilar...

Roche relying on Polivy’s $2B potential to weather biosimilar storm


To help withstand brutal attacks from biosimilars for the cancer troika  ̶   Rituxan, Herceptin and Avastin  ̶  Roche relying has been relying on newer drugs. The Swiss pharma is now considering Polivy a bright opportunity to deal with the previously bore losses.

Investors during a conference were told that for the recently diagnosed Diffuse Large B-cell Lymphoma (DLBCL), the antibody-drug conjugate, Polivy, may possibly be approved, if successful, for which the key readout will be available in coming weeks. The indication’s sales potential, worldwide, is up to $2 billion, Bill Anderson, Chief of Roche pharma, stated.

FDA approval in mid 2019, allowed the use of Polivy for treating the patients of DLBCL, after at least two prior therapies. Bill Anderson referred this field to have “limited growth potential.” Certainly, in first six months, the drug only earned up to CHF 94 million ($103 million), after 17% year-on-year growth.

The phase 3 trial of the recently diagnosed DLBCL, named Polarix, sets up a combination of Polivy with Roche relying manufactured Rituxan and a triplet chemotherapy called CHP, counter to the standard treatment, R-CHOP, which makes a combination of Rituxan with a chemotherapy regimen.

According to Anderson, the indication could determine the future of Polivy. If it gets successful, it could be first positive study in front-line DLBCL in 17 years.

With a positive study, he said that there can be high chance of acceptance of Polivy because it is capable enough to cure DLBCL.

As a consequence of the U.S. biosimilar assault, business of Roche relying pharma has been struggling with the decline in sales of three of its cancer blockbusters: Rituxan, Herceptin, and Avastin, as biosimilars to these three drugs together have eaten up CHF 2.85 billion from company’s top sales.

While Roche relying was facing hard financial times, the drugs which came among the products to help the company were the COVID-19 drugs. 

For treating mild-to-moderate patients of COVID-19, the first country to fully approve Ronapreve, a COVID-19 antibody therapy, which is a combination of casirivimab and imdevimab, was Japan. This Roche-Regeneron-partnered drug is under progressing evaluation with the European Medicines Agency.

Actemra, a drug used to cure Rheumatoid Arthritis, had brought in CHF 863 million sales in the second quarter. Hence the drug is ranked as the Roche’s third best-selling drug by quarterly sales, after multiple sclerosis antibody, Ocrevus, (CHF 1.21 billion) and HER2 cancer med, Perjeta, (CHF 980 million). The company’s business returned to a 4% year-on-year sales growth in the long run. Prior to that, it faced a 9% decline in the first quarter. According to the CEO, Severin Schwan, the company’s performance got slowed down due to the pandemic last year. Therefore, the company has a very low base to compare to.

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