Novartis biosimilar rivals Amgen offering
pharmafile | December 9, 2014 | News story | Sales and Marketing | Amgen, Neupogen, Novartis, Sandoz, filgrastim, zarzio
An investigational biosimilar by Novartis’ generic pharma arm Sandoz has been found to have comparable safety and efficacy readings to an already-approved breast cancer drug by Amgen.
Phase III data demonstrated similarities to Amgen’s Neupogen (filgrastim) during its PIONEER study, which compared the protection and value of the compounds in the prevention of neutropenia in patients with breast cancer.
A total of 218 people receiving neoadjuvant myelosuppressive chemotherapy took part in Novartis’ randomised trial.
“We are pleased by these clinical study results as they confirm the similarity of our investigational biosimilar filgrastim compared to the reference product in terms of safety and efficacy,” says Mark McCamish, head of global biopharmaceutical and oncology injectables development at Sandoz.
“The data from this important study also reinforces the results we have seen in earlier stages of development including multiple Phase I, pre-clinical and analytical studies. We look forward to making this product available to patients and healthcare providers in the US.”
Earlier this year the FDA accepted Sandoz’s application for its breast cancer treatment, this makes the Novartis-owned firm the first to have a filing accepted under the new US follow-on biologics pathway.
Biosimilars are more difficult to create than other generics, and must go through a similar clinical trials process as new drugs to prove they are as safe and efficacious as the drugs they copy.
This makes the method much longer and more expensive than with generics, but it can be highly lucrative, as there will be little biosimilar competition due to the complexities in manufacturing the drugs.
Already marketed in 35 countries under the brand name Zarzio, Sandoz’s follow-on biologics medicine is also being used in people who are about to donate blood stem cells for transplant. The drug helps to release these cells from the bone marrow.
Brand name drugmakers versus generic rivals
Last month it was announced that Amgen had filed a lawsuit and a citizen’s petition against Sandoz regarding the ‘copycat’ breast cancer biosimilar filgrastim.
Amgen is accusing Sandoz of not following the rules governed by the Biologics Price Competition and Innovation Act. The biotech recommends that there is a legal obligation to provide the firm with a copy of the follow-on biologics treatment in question.
Amgen argues that the lack of information means it will be unable to determine the extent to which there may be instances of patient infringement.
A Sandoz spokesman told The Wall Street Journal that: “Amgen’s lawsuit in relation to our biosimilar application comes as no surprise. As Sandoz is the first company using the pathway to bring cost-effective biosimilars to market in the US, it is understandable that Amgen and Sandoz might take a different view of the BPCIA provisions. We look forward to the court’s resolution in this matter.”
Tom Robinson
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