When we hear “blockbuster”, most of us immediately think of an oral small-molecule pill like Lipitor or Prilosec; however, modern blockbusters are much more complex biologic drugs.
Big pharma is making preparations to anticipate their patent expiry, which could reduce sales.
Humira
Blockbuster sales in the drug business are essential to profitability, yet when their monopolies expire, less expensive generics could threaten to take away their revenues – forcing drugmakers to find replacement top-selling medications quickly.
Humira is a biologic medicine designed to combat tumor necrosis factor (TNF), an intracellular protein responsible for swelling and tissue damage that contributes to Crohn’s disease and ulcerative colitis autoimmune conditions, as well as being used in cancer therapy treatments. Additionally, this therapy has also proven successful against Crohn’s and ulcerative colitis diseases. Additionally, Humira may be used as part of cancer chemotherapy treatment plans.
AbbVie anticipates that Humira sales will decline significantly this year and through 2029 due to patent cliff, but has other products to help offset this loss, including mergers with Allergan and Shire as well as orphan indications with small patient populations that provide seven additional years of exclusivity allowing it to delay biosimilar entry and protect its revenue stream.
Keytruda
Merck’s top-selling cancer drug Keytruda generated sales of $4.534 billion during the third quarter, making it the world’s best-selling medicine. Keytruda was the first among PD-1/L1 immunotherapy drugs to demonstrate benefit for post-surgery non-small cell lung cancer patients; market share is projected to increase further when Roche launches Tecentriq next year.
Blocking the interaction of PD-1 and PD-L1 proteins – normally responsible for keeping cancer cells hidden from being detected by your immune system – reactivates it so your body can begin fighting cancerous cells effectively, stopping their spread and eliminating cancer altogether.
As indication expansions decline and Medicare price negotiations on existing drugs come to a close, pharmaceutical companies face an uphill battle recouping revenue from older blockbuster drugs. Lawmakers must build upon recent major progress made toward bipartisan market-based solutions for Big Pharma accountability – click HERE for more info!
Opdivo
Nivolumab (Opdivo) is an immunotherapy used to treat melanoma and certain types of lung cancer. Additionally, it’s also an effective solution for treating squamous cell carcinoma of the esophagus; and can even be used when other treatments have failed.
Pharmaceutical companies invest billions of dollars annually in research and development, with some products becoming blockbusters that generate multibillion-dollar annual sales. Unfortunately, several of these drugs may soon lose patent protection, leading to generic competitors entering the market at reduced prices.
Some of the industry’s top drugs will lose their monopolies this decade, including AbbVie’s anti-inflammatory medicine Humira and Merck & Co.’s top-selling cancer medicine Keytruda as well as Bristol Myers Squibb’s immunotherapy Opdivo and Regeneron’s eye disease drug Eylea from AbbVie; however, this patent cliff differs from previous ones because many affected drugs are biologics created using living sources such as animals or people rather than traditional patent cliffs made from traditional substances made by humans or animals or humans from living sources that had patent protections.
Stelara
Drugmakers’ profits from blockbuster medicines enable them to invest in research and development for new ones, while high prices encourage patients to use them – keeping demand up and increasing demand. Some even argue that higher prices justify developing cures for diseases like cancer, heart disease and type 2 diabetes.
At previous patent expirations dates, small-molecule drugs dominated the top sellers list; but this year many of the big-seller products that will lose exclusivity are biologic treatments made from living cells instead of chemical pills. They will likely generate less revenue as biosimilar copies enter the market – an effect known as biosimiliarity.
Stelara, which treats plaque psoriasis, psoriatic arthritis and Crohn’s disease, could face competition from Amgen Inc’s biosimilar Repatha. J&J’s $30 billion medical devices business could help cushion against an impending patent cliff for Stelara according to CFRA analyst Sel Hardy.
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