Over the course of just five years, the global market in biosimilar medicines has risen to over $5 billion. Biosimilars are complex drugs identical to a branded one, but manufactured by a different company.
An indication of the size of the biosimilars market is drawn out from a review commissioned by McKinsey, who predict that during the course of 2020 sales of biosimilars are set to triple in size to $15 billion. With this, a number of new pharmaceutical companies are emerging with 'agile' being the governing philosophy, able to take an array of off-patent medicines and manufacture them to scale.
The idea behind biosimilars, put into law during the last days of the Obama administration in the U.S., is with increasing the supply of affordable medicines. Biosimilars (also described as follow-on biologics) are topes of medical products that are a copy of an original product. The difference being that the drugs are now manufactured by a different company, generally at a lower cost. Biosimilars are able to be manufactured when the original product's patent expires.
Biosimilars are different to generics medicines ('generics') in that they need to be exactly the same as the original branded product (whereas generics only need to be close to another product, such as with containing the same active ingredient). Biosimilars (and biological medicines in general) also tend to be far more complex than generics (developed using very large, complex molecules), and require precise replications of each manufacturing process.
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To gain approval, biosimilars need to be thoroughly tested through clinical trials in order to show that they work as effectively and are equally as safe as the original biological medicine.
A further trend with biosimilars is were 'big pharma' companies are setting up new enterprises to manufacture and market biosimilar drugs. in February 2020, Merck & Co announced a new strategy to produce older drugs in its pipeline together with biosimilars via a new stand-alone business. The new company has yet to be named; however, “NewCo” will be a standalone business with a separate stock market listing.
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Among the product portfolio, will be Merck’s biosimilar medicines in collaboration with Samsung Bioepis; a contraceptive implant called Nexplanon (genetic name etonogestrel); plus a cholesterol drug called Zetia (ezetimibe).