Hospira presents at European Biosimilars Forum, announces new White Paper on extrapolation

April 27, 2015 7:36 AM

Hospira, Inc., spoke about the importance of extrapolation in bringing biosimilars to patients at the European Generics Association (EGA) annual European Biosimilars Group conference in London.

The company also announced the publication of a pivotal white paper titled, “Why extrapolation is paramount to achieving the full promise of biosimilars.”

Speaking at the EGA conference, Sumant Ramachandra, M.D., Ph.D., senior vice president and chief scientific officer, Hospira, and one of the authors of the white paper, said, “Extrapolation is fundamental to biosimilar manufacturers who are delivering high quality biologic medicines at competitive prices. As the global population ages and more people are living with severe, chronic diseases, the pressure on healthcare budgets is only going to increase.

“The success of the biosimilar market depends on the adoption of sensible policies that do not squander the potential of these new therapies to reduce costs and improve access,” continued Ramachandra.

Extrapolation is the scientific concept of granting a clinical indication to a medicine without requiring new clinical efficacy and safety data to support an indication. Provided the in-depth laboratory and clinical studies have proven that a biosimilar and reference product are comparable, both in terms of the molecule’s structure and function in the body, it can be expected that the medicines will act in the same way.

The white paper highlights the significance of extrapolation in the development of a successful and sustainable biosimilars market. Real-world cost savings and increased patient access to life-saving medicines can be achieved by conducting only scientifically necessary clinical trials, it states, while also calling for more regulatory agencies to adopt the principle of extrapolation.

In the white paper, Ramachandra notes that the scientific principle for extrapolation has already been adopted by the European Medicines Agency (EMA) and that the European Commission (EC) has approved 21 biosimilar medicines in Europe, including the first biosimilar monoclonal antibody, Inflectra, in September 2013. In addition, the U.S. Food and Drug Administration (FDA) utilized extrapolation to approve the first biosimilar in the United States, biosimilar filgrastim, last month for all the therapeutic indications of the reference product that were available at that time.

The white paper further illustrates the benefit of extrapolation to improving patient access to important therapies. As one example, in the United Kingdom (UK), biosimilar filgrastim which stimulates the production of white blood cells in patients who have received cancer chemotherapy has increased patient access by 50 percent since it was introduced by Hospira and other companies.

“Hospira is dedicated to increasing patient access to safe, effective and high-quality medications and considers it our responsibility to provide education to the healthcare industry, medical professionals, insurers and the public about biosimilars and the extrapolation concept on which the biosimilar market is based,” said Paul Greenland, vice president, Biologics, Hospira, who also spoke at the EGA conference.

Biosimilars are cost-effective biologic medicines with the same quality, safety and efficacy as the reference product on which they are based. Biosimilar medicines are evaluated for their comparability with the reference product and, based on the totality of evidence submitted to a regulatory body, the biosimilar may be approved for all the licensed indications of the reference biologic without undergoing clinical trials in every indication. Biosimilars are expected to produce savings of over €33.4 billion in Europe by 2020.

The 13th EGA-European Biosimilars Group Conference concluded last Friday in London. The annual conference brings together global experts in the biosimilars space to discuss key biosimilar topics and latest regulatory and market developments.

In Europe, biosimilars have helped lower costs by 20 percent to 30 percent. It’s estimated that biosimilars could save the U.S. healthcare system $20 billion annually.

With one of the largest biosimilar pipelines in the industry, Hospira has more than seven years of market experience in biosimilars. The company has several biosimilars on the European, Australian and Canadian markets, including Inflectra (infliximab), Retacrit (epoetin zeta) and Nivestim (filgrastim). Hospira has delivered more than 10 million doses of biosimilar medicines to patients worldwide.

The White Paper can be found here. More information about extrapolation can be found in a recently released infographic available here.


Source: Hospira press release

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