EMA accepts Sandoz's MAA for biosimilar pegfilgrastim

Sandoz, a Novartis company and the global leader in biosimilars, announced that the European Medicines Agency (EMA) has accepted their Marketing Authorisation Application (MAA) for its biosimilar to Amgen's EU-licensed Neulasta (pegfilgrastim) - a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF). Sandoz is seeking approval for the same indication as the reference product.

Commenting on today's milestone, Richard Francis, Division Head and CEO Sandoz said, "Securing five major regulatory file acceptances in five months demonstrates substantial progress on our long-term biosimilars investment strategy. Further advancing our biosimilars pipeline is an important priority for us this year and we'll continue to invest significantly in bringing our pipeline to patients."

Pegfilgrastim is a prescription medicine used in cancer patients (except those with chronic myeloid leukemia and myelodysplastic syndromes) to help with some of the side effects of their treatment. It reduces the duration of neutropenia (low levels of neutrophils, a type of white blood cell that fights infections) and the incidence of febrile neutropenia (neutropenia with fever) that are a result of their chemotherapy treatment. The incidence of febrile neutropenia (FN) occurring with common chemotherapy regimens is 25 to 40 per cent of treatment-naive patients

Pfenex gets early HSR clearance for collaboration with Hospira

Pfenex Inc., a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics including high value and difficult to manufacture proteins, announced that the Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) in connection with the exclusive collaboration agreement executed by the company on February 9, 2014 with Hospira, Inc. to develop and commercialize, PF582, Pfenex's biosimilar product candidate to Genentech's Lucentis (ranibizumab injection).

With the early termination of the applicable waiting period under the HSR Act, the collaboration agreement with Hospira is effective as of March 19, 2015 and the $51 million initial payment under the collaboration agreement is due to the company on or before the fifth business day following HSR clearance.

Biopharma - India Market

Industry experts are confident that there is no way for US to ignore India now. There is expertise, cost advantage and comprehension about biologics production which has led global pharma majors partner with many companies here, they point out.
For instance, till five years ago most biosimilar developing firms were contracting development of cell lines to USA and UK. Recently, however, this trend has changed with certain Indian firms, such as Reliance Lifesciences, Cipla and Biocon being able to develop cell lines in-house.

 

While the US depends on China and South East Asia for outsourcing, there is a clear sign that despite the Euro crisis, several companies are coming up in the European Union for the production of biosimilars and are looking at India. The European Medicines Agency guidelines are already in place for biosimilars and vaccines for Indian companies to initiate the process.
The demand for biosimilars is likely to increase as Indians are becoming more affluent and healthcare insurance coverage widens. Moreover, considering the cost advantages that India can provide, the country has a great potential for future growth in the biosimilars market.

The high cost of biologics has contributed to the increasing and unsustainable overall health expenses throughout the world. In the US, 43% of the drug budget for Medicare Part B is consumed by 6 biologic drugs. This immense burden has led many countries to develop a regulatory framework which can approve biosimilars to provide entry of low cost alternatives to originator drugs, according to Dr. Reddy’s Biologics Devpt Centre.