Autoimmune disease treatment becomes only the second biosimilar to be approved by the FDA
Pfizer will begin shipping its Inflectra treatment to US wholesalers in November. Inflectra, a biosimilar of Johnson & Johnson’s Remicade (infliximab), was approved by the US Food and Drug Administration in April 2016 for the treatment of a variety of illnesses, including Crohn’s disease, ulcerative colitis and rheumatoid arthritis.
Inflectra will become only the second biosimilar drug to be released in the US, with legal disputes delaying the release of other products, notably Sandoz’s Zarxio, a generic version of Amgen’s Neupogen (filgrastim). To date, the European Medicines Agency has approved 21 biosimilars for use in the EU, where Inflectra has been available since 2013.
Meanwhile, Pfizer has vowed to fight a decision by the Court of Appeal in London over the way in which generic versions of its best-selling drug Lyrica (pregabalin) are prescribed in the UK. The US pharmaceutical firm is suing Actavis (acquired by Teva pharmaceuticals in August), which markets pregabalin under its original use as a treatment for epilepsy, arguing that the generic is being dispensed for pain relief – a use for which Pfizer retains a secondary patent.