What are biosimilars?
A biological medicine is a type of treatment for long-term medical conditions such as rheumatoid arthritis, Crohn’s disease and psoriasis that’s given via a drip or an injection pen. A biosimilar medicine is simply a newer version of the original biological drug: as the name suggests, it’s highly similar to EMA-approved biological medicines in terms of safety, purity and potency, and it works in much the same way. There are no clinically meaningful differences, just minor differences in clinically inactive components being allowed, and they have to go through the same rigorous scientific assessments before becoming available on the market.
So how are they different to biological drugs? Well, instead of being created using chemical synthesis, biosimilars are synthesised from living organisms or their products, such as hormones, proteins yeast or bacteria. As a result, the molecules within the drug could vary slightly between different batches, which means research and development takes an average of about 10 years. In addition, biosimilars can only become available once a branded drug patent expires - and according to Pfizer, approximately 100 biologic products will lose patent or other protections by 2022, which means newer and cheaper biosimilar products will soon become available.