Revlimid: The Star Drug In U.S. For Indian Pharma Companies — BQ Exclusive

Indian pharmaceutical companies are betting on the copycat version of a cancer drug in the U.S. to shore up their fortunes even as they face price erosion and heightened competition.Sun Pharmaceutical Industries Ltd. became the eighth entrant in the U.S. and fifth Indian drugmaker to launch generic Revlimid (lenalidomide) capsules. Other domestic companies that have already entered this market are Natco Pharma Ltd. along with its marketing partner Teva Pharmaceutical Industries, followed by Dr Reddy's Laboratories Ltd., Zydus Lifesciences Ltd. and Cipla Ltd. in 2022.Sun Pharma reported a negligible market share of the generic version of Bristol Myers Squibb's Revlimid in March, the first month of its launch in the U.S., according to IIFL Securities.But the drug, which treats blood cancer, has been the star performer for companies like Natco Pharma and Dr Reddy's, which launched the drug exclusively and early on.Sales of generic drugmakers, however, are only expected to get better in the next two years even as more competition enters until January 2026, when it will be an open market for all players..The innovator, Celgene Corp., a wholly owned subsidiary of Bristol Myers Squibb, had entered into volume-limited agreements with the generic drugmakers, regulating the supply of the drug in the market.The market for Revlimid—a drug used to slow down or stop growth of cancer cells, as well as treat anaemia in patients with certain bone-marrow disorders—was around $8.7 billion in the pre-generic market, which is when only innovator drug existed, said Rahul Jeewani, pharma analyst with IIFL Securities Ltd.'The key attractiveness of this drug lies in the fact that it has a very large addressable market with limited price erosion because of the limited market-share deals structured by the innovator,' he told BQ Prime. 'This will remain a lucrative opportunity until January 2026, post which it becomes an open market.'.In its April report, JM Financial Ltd. said the innovator guided for $6.5-billion global Revlimid sales in the 2023 calendar year versus $10 billion in 2022, implying higher share for generics and new entrants.Bristol Myers Squibb had a pre-loss exclusivity market of around $9 billion in the U.S. and approximately $3 billion in Europe, Vishal Manchanda, a pharma analyst at Systematix, told BQ Prime. The company is expecting a $3–3.5 billion loss in global Revlimid sales in 2023, owing to generic competition. That implies that generics will have a healthy opportunity.Antique Stock Broking's pharma analyst, Monish Shah, also expects the market size of the drug to grow 5% each year. 'Around 2,00,000 patients globally are being added each year with 20,000 in the U.S. itself.'Therefore, Revlimid remains the key growth driver for India's top generic drugmakers for the next two years, with all vying for a piece of this pie..Because of the volume-limited agreements, Jeewani estimated that the 2023 financial year saw a decline of around 15% in the price of Revlimid due to competitive impact.With Aurobindo Pharma Ltd. planning to launch its generic version in September, and Lupin Ltd., Torrent Pharmaceuticals Ltd., Alembic Pharmaceuticals Ltd. and Alkem Laboratories Ltd. planning the same over the next one–two years, the market is getting more competitive, he said.Jeewani expects a decline of around 20% in the current fiscal and 35–40% in the 2025 fiscal as compared to the pre-generic price due to the volume-limited agreements.Manchanda of Systematix expects the price erosion to be steeper in 2023 than 2022—around 20-30% incrementally for CY22 levels—as there will be an increase in number of generic players selling Revlimid in the U.S.Antique Stock Broking's Shah, however, factors in a steeper price erosion on the drug and expects the innovator to have a market of $5 billion in the 2025 calendar year, while the generics will have a market of around $3.5 billion..While Sun Pharma's March volumes were negligible, Jeewani expects it to gain market share gradually, inching up to a 2–2.7% share and $150 million revenues in 2025 before loss of exclusivity in January 2026.He expects the opportunity to be bigger for Dr Reddy's with revenues of around $350–360 million in 2025.JM Financial also expects Dr Reddy's to be the biggest beneficiary of gRevlimid. 'On an annual basis, we expect Dr Reddy's to gain more market share/ volumes.' Shah, however, expects Natco Pharma to have the biggest market share at 33% by the 2025 fiscal, followed by Dr Reddy's at 8%. Zydus Lifesciences and Cipla are also expected to ramp up their market share from current 3% levels to 4% in the current fiscal FY24 and 6% by the 2025 fiscal, he said.

Revlimid: The Star Drug In U.S. For Indian Pharma Companies — BQ Exclusive

Revlimid is used to slow down or stop growth of cancer cells, besides treat anaemia patients with certain bone-marrow disorders.

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