The amendment – adopted by the Senate Health, Education, Labor and Pensions (HELP) Committee and sponsored by Senators Orrin Hatch, Kay Hagan and Mike Enzi - represents an important win for the biotechnology industry.
The Obama administration, the Federal Trade Commission (FTC) and groups including the America Association of Retired Persons (AARP) all have proposed much shorter periods of protection before allowing biosimilar products on the market.
A biosimilar, or follow-on biologic, is a product that attempts to replicate a biologic – a medicine which involves living organisms – and is similar, but not identical to, the innovator drug. Like their pharmaceutical counterparts, they are offered at discounted prices to patients.
But because biologics are more complex than the small molecule chemical drugs copied by generic pharmaceutical companies, it is not yet possible to make them identical to the reference product. This has made it necessary for regulators to develop alternative approval processes than those used for traditional generic drugs.
The House of Representatives is considering a separate bill, the Pathway to Biosimilars Act, which has 129 cosponsors and bipartisan support for at least 12 years of data exclusivity for biologics. The House also yesterday introduced a companion bill to the Senate’s health care reform package, which was referred for consideration by various committees.
It is possible that a provision on biosimilars could be adopted as an amendment to that package, as in the Senate.
The Affordable Health Choices Act was spearheaded by Senator Edward Kennedy of Massachusetts and other Senate HELP Committee democrats. The legislation would ensure that no American could be denied health coverage by insurance companies and would expand the options available to those who are not covered, including a community health plan option.
Yesterday the Biotechnology Industry Organization (BIO) testified before the House Judiciary Subcommittee on Courts and Competition Policy on the topic of biosimilars. Jeffrey Kushan of Sidley Austin, speaking on behalf of BIO, warned against shorter exclusivity periods for biologics.
He said: “Measures that operate to lessen the economic incentives of our current system will translate into fewer new biological products and therapies, to the detriment of patients with currently unmet medical needs.”
In a post on Biotech Now, BIO president and CEO, Jim Greenwood expressed excitement over the Senate victory, but said that there remains a long road ahead: “We are still a long way from finished. We might face battles on the Senate floor as well as in the House. But so far, so good.”
