In our December blog we lightly touched upon the topical subject of Biosimilar Blockbusters, talking about the EU and US patent expiry dates for the “big player” drugs, up to and including 2024. So, what does the future hold for them after 2024? Read on and find out!
Biosimilar therapeutics – highly similar copies of off-patent biopharmaceuticals – take, on average, 6-8 years to gain regulatory approval to be released onto pharmaceutical markets. The first biosimilar manufacturer to provide convincing evidence to the regulator, in the form of batch-to-batch comparative studies showing similarity in structure, safety and efficacy to the innovator, has first crack at the market once the RMP drug’s patent expires.
Several key drugs that are currently generating billions of dollars for pharmaceutical companies are coming to the end of their market monopoly. The next decade will see hugely lucrative pharmaceutical drugs falling off the “patent cliff”. Because of the time needed to develop a successful biosimilar, many companies and manufacturers are already working on many of these drugs. Let’s have a look at what they are (see Figure 1).
But the patent cliff is not just a simple “fall”. Patent thickets are a difficult labyrinth to navigate, usually made purposefully convoluted by the innovator companies to deter the manufacture of biosimilars or generics. The innovator companies will have first right of refusal for extending the original patent, but this doesn’t discourage other biotherapeutic companies developing biosimilars. Various legal strategies are employed by the innovator companies, such as the application of terminal disclaimers, which work to maintain their domination of the market for their biotherapeutic.
In short, companies developing biosimilars are facing lengthier and more expensive lawsuits centred around patent infringement, but many companies still believe the reward of bringing a successful biosimilar to market will outweigh the risk.
This is one of the reasons why we have observed an upward trajectory of emerging biosimilar therapeutics, with no indication of a plateau in sight. Controversies are starting to circle around patent thickets and the manufacturers’ roles in driving high drug prices and limiting access to affordable medicines. Ethical investors are now focussing on transparency and accountability, calling for fair prices and broader patient access to essential medications. These are the defining factors that give biosimilars the opportune niche in an otherwise saturated market.
Let’s take AbbVie’s Humira as an example, a drug which has over 100 patents associated with it. Sandoz gained FDA and EMA approval for their Hyrimoz HCF biosimilar in March 2023, quickly followed by product launches in July and November 2023 in US and EU respectively. In the US, a major pharmacy supplier brokered a deal with Sandoz to commercialise and launch a privately labelled Hyrimoz-HCF biosimilar which was priced 80% cheaper than the innovator drug.
Exciting biosimilars we can expect to make an appearance on the medicines markets, include Enbrel (Etanercept), Entyvio (Vedolizumab), Kadcyla (Trastuzumab emtansine), Prolia (Denosumab), Cyramza (Ramucirumab) and Abthrax (Raxibacumab) (US only), as well as Repatha (Evolocumab), Darzalex (Daratumumab), Opdivo (Nivolumab) and Ocrevus (Ocrelizumab) (EU and US markets), to name a few.
At BioPharmaSpec, we understand that the development and manufacture of any biosimilar can be complicated, and have worked with all of the biosimilars listed above and many, many more. We specialize in helping biosimilar developers accelerate their product to market, by performing structural comparability studies between the biosimilar and the innovator, thus providing a statement of similarity backed-up by robust batch-to-batch comparability data. Our multidisciplinary team has decades of experience in characterizing the structural and physicochemical attributes of innovators and biosimilars of many different classes of molecule.
Contact our scientists now with the name of your biosimilar molecule (e.g. Adalimumab, Enbrel, Insulin etc) to receive more information, including quotations for biosimilarity and batch-to-batch comparability studies.
Contact us to discuss how our scientists can use their expert knowledge of biosimilar comparability studies to generate characterization data for your biosimilar and the innovator as part of a structural characterization or analytical comparability package.
