Biosimilars continued their upward trend in 2016 and cemented their position as one of the most important and exciting areas of drug development in the industry at the moment.
Perhaps the biggest news was the FDA’s greenlight for the first biosimilar of AbbVie’s biologic Humira, the world’s second best-selling drug. Amgen’s Amjevita was been cleared for all eligible indications of its reference product, including moderate-to-severe rheumatoid arthritis, adult moderate-to-severe Crohn’s disease and moderate-to-severe ulcerative colitis.
However, as with other biosimilars such as Novartis’ copy of Amgen’s Neupogen, Amjevita faces legal challenges. Amgen may not be able to launch its drug until 2022, because AbbVie is claiming that it infringes patent protection on Humira that is valid until that date. The firms are currently battling the issue in the US Court for the District of Delaware.
This year also saw Celltrion and Pfizer’s biosimilar of Johnson & Johnson’s Remicade (infliximab) become only the second biosimilar approved in the US (and the first biosimilar monoclonal antibody, before Amjevita), while Sandoz’s biosimilar of Amgen’s blockbuster Enbrel, called Erelzi, became the third when it was approved for all of the originator drug’s indications targeting autoimmune diseases.
In the UK Biogen’s Flixabi – a biosimilar of Johnson & Johnson’s blockbuster infliximab – was approved for use in a range of chronic inflammatory conditions, including Crohn’s disease, adult ulcerative colitis, rheumatoid arthritis and psoriasis, and Teva UK launched its fertility treatment Ovaleap, a biosimilar alternative to Merck Serono’s Gonal-f.
But several questions surrounding biosimilars still remain. One lingering issue for healthcare systems is whether it is safe to switch a patient from an originator product to a biosimilar – although some of these concerns were eased when the NOR-SWITCH study, sponsored by the Norwegian government, found that switching from Remicade to Celltrion’s biosimilar caused no safety or
efficacy issues.
The lead feature in our July/August issue, Same Difference, looked at other issues such as the time needed to educate HCPs and help them understand biosimilars, and whether they should be considered as generics and treated
as such.
Aiming to address some of these issues and increase the understanding and use of biosimilars in the UK, a new industry body, the British Biosimilars Association was launched in April as a sector group of the British Generic Manufacturers Association.
“Currently, the UK lags behind some European countries in the take-up of biosimilar medicines,’ the Association said in a statement coinciding with its launch. “Restricting patient access to these medicines costs the NHS money that could be used for other treatments.
“BBA members’ core focus will be ensuring patients can benefit from these lifesaving and life-changing medicines to the same extent as those elsewhere in Europe.”
