Hospira highlighted the importance of extrapolation in bringing biosimilars to patients at a medical conference last week.
The company encouraged regulators to continue to adopt important scientific and clinical concepts of extrapolation, noting that Europe has 21 European Medicines Agency (EMA) approved biosimilars and the US Food and Drug Administration (FDA) has just approved the first biosimilar for use in the US in March.
Sumant Ramachandra, MD, PhD, senior vice president and chief scientific officer, Hospira spoke about this issue at the European Generics Association (EGA) annual European Biosimilars Group conference in London. Additionally, the company announced the publication of a pivotal white paper titled, “Why extrapolation is paramount to achieving the full promise of biosimilars.” Dr. Ramachandra was one of the authors of the white paper.
“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,” said Dr. Ramachandra. “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.”
Extrapolation is the scientific concept of granting a clinical indication to a drug 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 based on both the molecule’s structure and function in the body, it can be expected that the drugs will act in the same manner. The newly published white paper highlights the importance of extrapolation for development of a successful and sustainable biosimilars market. According to the paper, conducting only scientifically necessary clinical trials would provide real-world cost savings and increase patient access to life-saving medicines. The paper calls for more regulatory agencies to adopt this principle.
The EMA and the European Commission (EC) has already adopted the scientific principle for extrapolation, resulting in the currently 21 approved biosimilar medicines in Europe. Ramachandra noted that the FDA utilized extrapolation to approve the first biosimilar on March 6th for all indications of the reference product that were available at that time. According to the paper, in the United Kingdom (UK), biosimilar filgrastim 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. In Europe, biosimilars have helped lower costs by 20 to 30 percent. It is estimated that the emergence of biosimilars in the US could save the healthcare system $20 billion annually.
Ajay Ahuja, MD, MBA, Vice President, Medical Affairs at Hospira will be speaking about the market dynamics of biosimilars at Specialty Pharma Education Center’s (SPEC) upcoming Biosimilars 20/20 Conference, scheduled for June 3-4, 2015, in Philadelphia, PA. For more information on the conference visit: http://biosimilars.specialtycme.org/.
Source: Hospira, Inc.
Last updated: 4/29/15; 10:10am EST