New forum expands access to biosimilars

The need for credible, sustained, and unbiased biosimilars education has fueled the development of the Biosimilars Forum.

The Biosimilars Forum was launched on May 5, 2015 as a non-profit organization to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines and improving healthcare. The founding members created the forum based on the need for a sustained and unbiased biosimilars education and advocacy program in the United States.

A biosimilar is approved based on a showing that it is highly similar to an FDA-approved biological medicine, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.

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To this end, the development of an independent nonprofit forum to raise awareness of biosimilars and serve as a credible resource for information is timely,” said Juliana Reed, president of the Biosimilars Forum. “The [Forum] will provide an opportunity for companies developing biosimilars for the United States to work together and with other key stakeholders on topics instrumental to biosimilars and patient care.”

The Biosimilars Forum will:

• Conduct educational outreach to the healthcare community and patients

• Advocate for public policies that support access and adoption of biosimilars at the national and state levels

• Advocate for reimbursement policies that will help expand access to biosimilars

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The founding members of the Biosimilars Forum represent the majority of companies with the most significant US biosimilars development portfolios, including: Actavis, Amgen, Boehringer Ingelheim, Coherus BioSciences, EMD Serono, Hospira, Merck, Pfizer, Samsung, Sandoz, and Teva.

The members of the forum have elected the following executive officers: President, Juliana Reed, Vice President, Global Government Affairs, Hospira, Inc.; Vice President, Hillel Cohen, Ph.D., Executive Director, Scientific Affairs, Sandoz Biopharmaceuticals (a Novartis company); Treasurer, Geoffrey Eich, Executive Director, External Affairs Amgen Biosimilars; and Secretary, Stacie Phan, Director, State Government Affairs and Public Policy, Boehringer Ingelheim.

FDA’s approval of the first biosimilar in the United States and the ongoing development and production of several other biosimilars serve as key milestones, according to Reed.

“It is important to help expand education and awareness about biosmilars including their safety, efficacy, and an understanding of the FDA approval standards to help clinicians and patients make informed choices, as well as improve the understanding of the public at-large,” she said.

The benefits attributed to the use of biosimilars are significant, according to Reed.

“In the European Union, where biosimilars have been approved for use since 2006, clinicians and patients have benefited from the use of millions of doses of biosimilar medicines,” she said.

An analysis conducted by the Congressional Budget Office estimated that the introduction of biosimilars would reduce drug spending by roughly $25 billion over 10 years, saving the federal government nearly $6 billion.

“Access to biosimilars will help clinicians and formulary managers have expanded treatment options,” Reed said.”Biosimilars may help patients, clinicians, and payers access important biological medicines and reduce healthcare costs.”

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