NICE Approves Two Biosimilars for Arthritis

02.02.2016 -

Rheumatoid arthritis sufferers in England will soon be able to benefit from a cheaper generic version of US pharmaceutical producer Merck’s and the world’s best-selling medicines, Remicade, following a decision by the National Institute for Health and Care Excellence agency, NICE.

In the move designed to reduce costs for the National Health Service (NHS), the agency has approved two biosimilars to take their place in the NHS approval listing alongside the original drug, while recommending that patients be started on the least expensive drug.

Marketed in Europe by Merck Sharp & Dohme – as the drugmaker is known outside the US and Canada – and by Johnson & Johnson in the US, Remicade’s annual sales exceed $10 billion, making it the most commercially important drug to face competition from biosimilars.

In addition to Remicade, NICE, whose approval must be sought by drugmakers seeking access to the NHS for new medicines, also has recommended Inflectra, a biosimilar made by Pfizer, and Remsima, a drug marketed by Napp Pharmaceuticals, both for treatment of severe rheumatoid arthritis.

As all three products are considered to have equal medical benefits but the two biosimilars are priced lower than the branded drugs, they are expected to gain market share quickly if physicians abide by NICE’s recommendation to start patients on the cheapest version.

Experts note, however, that due to the higher cost of development and manufacturing. biosimilars do not offer as much cost-saving as traditional generics. Biological therapies are generally more difficult to replicate.

According to their list prices, the biosimilars cost £377.66 per 100 mg vial, which is 10% less than Remicade at £419.62. However, the NHS is said to have negotiated a much bigger rebate.

The global biosimilars market is forecast to reach $55 billion by 2020, according to research by GBI.