The Next Big Patent Cliff
By mid of this decade, biopharma giants are staring at huge patent cliffs, with financial pressure building for many key blockbuster brands which face loss of exclusivity (LOE). Probably, for the very first time, a host of innovator biologic brands are set to face stiff competition from biosimilar entry, between 2025 - 2030, making a combined revenue loss of $200m, as projected by analysts.
According to ZS Associates, the top 10 pharmaceutical manufacturers combined have more than 46% of their revenues at risk during that time frame, including Pfizer, Novartis, Merck, Eli Lilly, BMS. Case in the point being, Roche, last month, woke up to the news of the U.S. FDA approval of Alymsys (bevacizumab biosimilar), by Amneal, a NJ based biopharma. It marked the second bevacizumab biosimilar approval in 2021, and third in overall. The biosimilar wave is evident in Roche's Q1 earnings report?for 2022 that revealed significant decreases in revenue thanks to increased biosimilar competition in not only bevacizumab, but also the trastuzumab and rituximab markets. Sales were hit by a margin of 19% to 32% for the 3 reference products compared to Q1 2021 performance.
This obviously doesn't mean that biosimilar manufacturers are hoping for a windfall, as innovator companies are known to adopt brand lifecycle strategies (patent extension), modification and/or new product launches to offset the same. Roche for example, appears to have developed a viable defense against ranibizumab biosimilar competition for Lucentis, the company’s product for wet AMD, by winning the FDA’s approval of a ranibizumab implant called Susvimo, in Oct 2021. Susvimo offers patients convenience of an eye implant containing a reservoir of ranibizumab good for 6 months compared to alternative monthly injections. Come June 2022, the implant application success in the market however, will be put to test, by more affordable biosimilars (Biogen's Byooviz) as a monthly injection regimen. A rather cruel twist in the tale for Roche's Susvimo though, could be the reported 3-fold higher rate of endophthalmitis, an infection inside the eye, caused by intravitreal injection. Will patients stick to monthly injections, paving way for biosimilars to dominate the age-related macular edema market? We will have to wait for that story...
Source: Company financial filings, patent settlement agreements, Scrip & Biomedtracker
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The timeline above, gives a clear picture of how major biopharma companies are looking at big revenue losses to impact their bioloigc drug portfolios, owing to LOE erosion by 2030. SVB Leerink analyst Geoff Porges, in Dec 2021 forecast estimated that BMS,?Amgen, & Pfizer will face the biggest impact from LOE erosion with 47%, 29% and 28% resp. posing a danger for the respective franchises & commercial team.
Yet, the purported silver lining for some monoclonal antibody brands, is that, the LOE event is not quite similar to what the pharma business world has witnessed in the past decades with the ushering of generics to small molecule blockbusters like Lipitor (atorvastatin) or Plavix (clopidogrel). Certain innovator biologics are unique in the way, that despite, sharing market space with their biosimilar competitors, they continue to contribrute to the top line and beat expectations. One such glorious example would be J&J's Remicade (Infliximab), which was first approved in US in 1998, followed by EU the next year. Infliximab is used for the treatment of rheumatological, gastroenterological and dermatological disorders that are refractory or unresponsive to conventional modalities. There are now at least 13 registered Infliximab biosimilars globally, most notable ones being:
Other non-originator/ copy brands which got subsequent FDA approval are Ixifi (Pfizer), Zessly (Sandoz), Avsola (Amgen). Despite patent expiry of Remicade, Infliximab biosimilars have only reached maximum of 37% market share, since 2016; a 5 year time frame which failed to dominate the immunology landscape. One strong reason believed to have contributed to the continued sales turnover of Remicade is the hesitation of physicians switching to biosimilars in the U.S. For example, a survey noted only 11% of rheumatologists said they were comfortable switching existing patients and 42% were comfortable starting new patients on biosimilars instead of the originator. The optimism to switch to biosimilar is higher with oncologists though, possibly due to better payment models for oncology treatment. Another reason for generous top line sales of Remicade could be the alleged mark up of prices in physician's office compared to specialty pharmacies. The cost implication builds up as most of these biologics require multiple dose administration and repeated visit to a hospital or clinician.
Interestingly enough, such blockbuster brands not only enjoy peak productivity, but also a long tail of top line sales.
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2 年Everlasting is what originators are champions at...