Biosimilar

Phase III data shows Sandoz’ investigational biosimilar filgrastim has similar safety and efficacy as Amgen’s NEUPOGEN®.

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  • Pivotal PIONEER study compared safety and efficacy of the two compounds in the prevention of neutropenia in patients with breast cancer
  • PIONEER data supported filing for biosimilar filgrastim in the US
  • The abstract of the study results is published online as part of the 56th American Society of Hematology (ASH) Annual Meeting and Exposition

 

Holzkirchen, December 8, 2014 – Sandoz, a Novartis company, announced today Phase III data that demonstrated similarity of its investigational biosimilar filgrastim compared to the US-licensed reference product, Amgen’s NEUPOGEN ® (filgrastim) in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. The study also showed that repeated switching at each cycle between the investigational biosimilar and the originator filgrastim showed no impact on efficacy, safety or immunogenicity.

 

The PIONEER study was a Phase III study designed to compare the efficacy and safety of the investigational biosimilar and the reference product with respect to mean duration of severe neutropenia following Cycle 1 chemotherapy. PIONEER was a randomized, double-blind, four-group, multi-center non-inferiority trial conducted at 27 centers. The trial randomized 218 breast cancer patients receivingneoadjuvant myelosuppressive chemotherapy.

 

On July 24, Sandoz announced that the FDA accepted its application for filgrastim, making Sandoz the first company to have a filing accepted under the new US biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The Phase III PIONEER study results supported this filing.“Biosimilars can play an important role in broadening access to high-quality biologics in the United States,” said Prof. Kimberly Blackwell, MD, Professor of Medicine, Assistant Professor of Radiation Oncology, Duke University School of Medicine. “I’m also optimistic that the savings generated through the use of biosimilars can be used to fund other unmet medical needs.”

 

“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,” said Mark McCamish, M.D., Ph.D., Head of Global Biopharmaceutical & 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 United States.”

 

Sandoz is the global market segment leader with over 50 percent volume share of all biosimilars approved in North America, Europe, Japan and Australia.  Sandoz currently markets three biosimilars outside the US; each of which occupies the #1 biosimilar position in its respective category. Sandoz biosimilars are sold in over 60 countries and have generated over 170 million patient-exposure days in experience. Sandoz also has a robust pipeline with six molecules in Phase III clinical trials/registration – more than any other company in the industry.

What are biosimilars and are they important?

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Abstract

All prescribers will be familiar with the issues associated with the use of branded and generic ‘chemical’ medicines.1 For biological products (e.g. epoetin, filgrastim), a biosmilar medicine is a new biological product that is similar to a medicine that has already been authorised to be marketed in the EU (the biological reference medicine).2 Six biosimilar medicinal products are currently marketed in the UK—three versions of filgrastim (▼Nivestim, ▼Tevagrastim and Zarzio),3–5 two versions of epoetin (Binocrit and Retacrit)6,7 and one version of somatropin (Omnitrope).8 Applications for biosimilar versions of follitropin alfa and infliximab are under evaluation by the European Medicine’s Agency (EMA) Committee for Medicinal Products for Human Use.9 In the future there may also be biosimilar versions of insulins, recombinant vaccines, interferons and monoclonal antibodies such as rituximab and trastuzumab.10 It is estimated that about 50% of the current UK market for biological medicines by spend may be subject to biosimilar competition by 2019. In this article, we will consider the background to developing biosimilar medicines, how and why they differ from traditional generic medicines in their licensing requirements and the issues that may arise as they are introduced to clinical practice.

Source: BMJ