A US Food and Drug Administration (FDA) advisory committee voted unanimously in favour of Sandoz’s biosimilar in July, and yesterday the Agency announced its approval of Erelzi for the treatment all five indications of Amgen’s Enbrel (etanercept).
Erelzi becomes the third biosimilar to be granted approval in the US, and the first version of Enbrel.
“We are proud to be the first to receive regulatory approval,” Sandoz spokesman Chris Lewis told Biopharma-Reporter.com. “As a global leader with over a decade of experience in commercialising biosimilars in highly-regulated markets around the world, we have tremendous experience to draw on.”
Novartis subsidiary Sandoz was the first to market a biosimilar in the US when it launched Zarxio - a version of another Amgen biologic Neupogen (filgrastim) - last September. The second approved US biosimilar, Pfizer/Celltrion’s Remicade (infliximab) copycat Inflectra, is expected to launch in October.
Lewis said Sandoz is “fully committed to bringing Erelzi to US patients and payors asap,” but would not comment at this stage on launch timing.
Following a US Court of Appeals for the Federal Circuit ruling last month, Sandoz must now provide Amgen with at least 180-days’ notice before it intends to launch commercially, so the US could see Erelzi available as early as February 26 next year.
According to Lewis, “Erelzi will be manufactured at state-of-the-art facilities in Europe, where Novartis products are also manufactured,” though further details were not disclosed.
In June, Biopharma-Reporter visited the firm’s Schaftenau, Austria plant which – along with a nearby plant – will see investment totalling $1bn by the end of the decade in order to “bring all of [Novartis’] biologics manufacturing under one roof.”
Biosimilar but not interchangeable
Like Zarxio and Inflectra, the US FDA has deemed Erelzi biosimilar but not interchangeable, meaning it may not be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product.
According to the FDA, an interchangeable product is: “expected to produce the same clinical result as the reference product in any given patient,” and “when administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the biosimilar product and its reference product is not greater than the risk of using the reference product alone.”
However, industry still awaits clarification from the Agency about how to prove a product is interchangeable.
Enbrel in Europe
Sandoz is not the first company to achieve success in developing an etanercept biosimilar.
Korean firm Samsung Bioepis – a joint venture between Samsung Biologics and Biogen - received EMA approval for its etanercept biosimilar Benepali in January, and has already begun rolling out the product across Europe.
Sandoz’s Enbrel biosimilar was accepted by the European Medicines Agency (EMA) last December.