Senate Committee on Health Hears Testimony on Follow-on Biologics
by Aaron F. Barkoff
Orange Book Blog
The U.S. Senate Committee on Health, Education, Labor, & Pensions held a hearing this morning on follow-on biologics. A complete video recording is available on the hearing web-page. The written testimony of each witness is available on the same page (click on the red icon appearing after each person's name).
In opening remarks, Sen. Kennedy (D-MA), the Chairman of the Committee, noted that he recently sat down with leaders of several biotechnology companies based in his home state of Massachusetts. He expressed his belief that any regulatory scheme for follow-on biologics must be guided by three principles: (1) it must be led by the science; (2) protecting patients' safety is essential; and (3) innovation must be valued and promoted. Sen. Enzi (R-WY), the Republican leader on the Committee, echoed Sen. Kennedy's remarks. He emphasized, "we must not rush a solution through Congress," or else "we risk endangering lives." Sen. Clinton (D-NY), a co-sponsor of the Access to Life-Saving Medicine Act, which would establish an abbreviated pathway for the approval of follow-on biologics, sensed that all sides acknowledge that science has advanced far enough to make follow-on biologics a reality. She said, "we are debating how, not if, and it will be up to this committee when."
Sen. Schumer (D-NY), also a co-sponsor of the Access to Life-Saving Medicine Act, was the first witness to speak. He began by announcing that "the science is there now." Sen. Schumer made a few points regarding the European Union's framework for regulating follow-on biologics (or "biosimilars," as they're called in Europe). He said the EU has a highly regulated system that's "arguably burdensome." He noted that Europe has approved only two biosimilars in the four years since the EU's regulatory framework has been in place. With regard to patent rights, Sen. Schumer said that the Hatch-Waxman Act struck a balance, but in his view created an imbalance for biologics since biologics can receive five years of New Chemical Entity exclusivity and seven years of Orphan Drug Exclusivity, but are free of competition from generics.
Following Sen. Schumer, the Committee heard from a panel of four experts:
In the question and answer session that followed, all four panelists seemed to agree that the FDA currently has the expertise and is equipped to properly regulate follow-on biologics. Moreover, the four panelists agreed that the primary goal is ensuring patient safety. The panelists (and certain Senators on the Committee) disagreed about whether the Access to Life-Saving Medicine Act, as currently written, adequately protects patient safety. Sen. Hatch (R-UT) stated clearly that he cannot support the current bill due to safety concerns. Sen. Clinton hinted at possible amendments to the Act that might represent a compromise.
Source: OrangeBookBlog.com
RELATED READING:
- BIO press release
- Bloomberg article
- Boston Globe article
- Johnson & Johnson press release
- PCMA press release
- Reuters article
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Orange Book Blog
The U.S. Senate Committee on Health, Education, Labor, & Pensions held a hearing this morning on follow-on biologics. A complete video recording is available on the hearing web-page. The written testimony of each witness is available on the same page (click on the red icon appearing after each person's name).
In opening remarks, Sen. Kennedy (D-MA), the Chairman of the Committee, noted that he recently sat down with leaders of several biotechnology companies based in his home state of Massachusetts. He expressed his belief that any regulatory scheme for follow-on biologics must be guided by three principles: (1) it must be led by the science; (2) protecting patients' safety is essential; and (3) innovation must be valued and promoted. Sen. Enzi (R-WY), the Republican leader on the Committee, echoed Sen. Kennedy's remarks. He emphasized, "we must not rush a solution through Congress," or else "we risk endangering lives." Sen. Clinton (D-NY), a co-sponsor of the Access to Life-Saving Medicine Act, which would establish an abbreviated pathway for the approval of follow-on biologics, sensed that all sides acknowledge that science has advanced far enough to make follow-on biologics a reality. She said, "we are debating how, not if, and it will be up to this committee when."
Sen. Schumer (D-NY), also a co-sponsor of the Access to Life-Saving Medicine Act, was the first witness to speak. He began by announcing that "the science is there now." Sen. Schumer made a few points regarding the European Union's framework for regulating follow-on biologics (or "biosimilars," as they're called in Europe). He said the EU has a highly regulated system that's "arguably burdensome." He noted that Europe has approved only two biosimilars in the four years since the EU's regulatory framework has been in place. With regard to patent rights, Sen. Schumer said that the Hatch-Waxman Act struck a balance, but in his view created an imbalance for biologics since biologics can receive five years of New Chemical Entity exclusivity and seven years of Orphan Drug Exclusivity, but are free of competition from generics.
Following Sen. Schumer, the Committee heard from a panel of four experts:
Sid Banwart, VP of Human Services for Caterpillar, noted that prescription drugs account for 25% of Caterpillar's health care spending for its 95,000 employees worldwide. He expressed concern that biologic drugs are the "single fastest growing category of health costs" for Caterpillar, having increased 45% since 2004, and stated that "the trend is not sustainable."
Dr. Jay Siegel, President of Biotechnology R&D at Johnson & Johnson and a 20-year veteran of FDA's Center for Biologics Evaluation and Research, provided the innovator/biotechnology company perspective. In his view, pre-marketing clinical trials of biologics in humans should always be required. Moreover, Dr. Siegel believes follow-on biologics should not be substitutable with innovator biologics because the two can never be identical. Of course, substitution at the pharmacy level is the holy grail for the generics industry, since that's where the real money is.
Nicholas Rossignol, Administrator of the European Commission Pharmaceuticals Unit, spoke next. He emphasized that there is a range of complexity in biologics (e.g., a vaccine is much more complex than a small protein such as insulin), which must be considered in any regulatory scheme. He explained that substitutability is regulated at the individual country level in Europe, and some European nations have allowed substitution of certain follow-on biologics.
Finally, Dr. Ajaz Hussain spoke on behalf of Sandoz and provided the generic industry's perspective. Dr. Hussain expressed his belief that substitutability is an important public health goal and that follow-on biologics can be made to be substitutable.
In the question and answer session that followed, all four panelists seemed to agree that the FDA currently has the expertise and is equipped to properly regulate follow-on biologics. Moreover, the four panelists agreed that the primary goal is ensuring patient safety. The panelists (and certain Senators on the Committee) disagreed about whether the Access to Life-Saving Medicine Act, as currently written, adequately protects patient safety. Sen. Hatch (R-UT) stated clearly that he cannot support the current bill due to safety concerns. Sen. Clinton hinted at possible amendments to the Act that might represent a compromise.
Source: OrangeBookBlog.com
RELATED READING:
- BIO press release
- Bloomberg article
- Boston Globe article
- Johnson & Johnson press release
- PCMA press release
- Reuters article
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