Follow-on Biologics News Briefs - No. 9

    By Donald Zuhn --

Patient Groups Back Senate and House Committee FOB Legislation

In September, twenty-seven patients' groups sent a letter to Sen. Harry Reid (D-NV), Sen. Mitch McConnell (R-KY), Speaker of the House Nancy Pelosi (D-CA), and Rep. John Boehner (R-OH), expressing their "strong support for the inclusion of a regulatory pathway for biosimilars in the America's Affordable Health Choices Act of 2009."  The groups urged Congress "to identify the appropriate balance between access, patient safety, and the need for continued innovation," and noted that they "were heartened to see complementary amendments passed by both Committees of jurisdiction in the Senate and House with strong bi-partisan support" (see "Senators Champion 12-Year Data Exclusivity in Senate" and "House Committee Approves Health Care Reform Bill Calling for 12-Year Exclusivity Period").  In particular, the groups expressed support for "the important, compromise Hagan/Enzi/Hatch and Eshoo/Inslee/Barton amendments which establish a regulatory pathway for biosimilars."

The signatories to the letter include:  AA CSA Foundation, Alliance for Aging Research, American Association of Orthopaedic Surgeons, American Autoimmune Related Diseases Association, American Institute for Medical and Biological Engineering, Californians for Cures, CANN - Community Access National Network, Celiac Disease Center at Columbia University, Children's Tumor Foundation, Colon Cancer Alliance, Community Health Charities, Dystonia Medical, Research Foundation, Easter Seals, Hereditary Disease Foundation, Immune Deficiency Foundation, In Need Of Diagnosis, Inc., International Cancer Advocacy Network, Lung Cancer, Circle of Hope, Men's Health Network, MLD Foundation, National Alliance on Mental Illness, Parkinson's Action Network, Research for Cure, RetireSafe, The AIDS Institute, Vietnam Veterans of America, and Vital Options International.

DelawareBio and BIO Seek Support of Delaware Delegation

On Monday, Bob Dayton, the President of the Delaware BioScience Association, and Jim Greenwood, the President and CEO of the Biotechnology Industry Organization (BIO), co-authored a letter on delawareonline, encouraging Delaware Sen. Thomas Carper (D), Sen. Edward Kaufman (D), and Rep. Mike Castle (R) to join them "in supporting a biosimilars pathway that protects patient safety and encourages continued innovation."  Noting that Senate and House committees had passed health care reform amendments that would establish a follow-on biologic regulatory pathway -- as well as provide a 12-year data exclusivity period for biologic drug makers (see "Senators Champion 12-Year Data Exclusivity in Senate" and "House Committee Approves Health Care Reform Bill Calling for 12-Year Exclusivity Period"), Mr. Dayton and Mr. Greenwood contend that "[t]he pathway to regulatory approval of biosimilars included in the House and Senate health care reform bills will ensure that these medicines are tested for safety while expanding access, lowering costs through expanded competition and providing incentives for biotech companies to continue innovating."  The biotech industry leaders also noted that "[p]atient advocates, doctors, labor unions, universities and governors, including Gov. Jack Markell, agree that the provisions must be included in the final health care bill" (see "Governors Send Letter to Congressional Leaders in Support of 12-Year Data Exclusivity Period").

Coalition for a Competitive Pharmaceutical Market Asks Congress to Fix FOB Provisions of Health Care Reform Legislation

Last week, the Coalition for a Competitive Pharmaceutical Market (CCPM) released a statement "appealing to Congress to fix the excessive 12-year market exclusivity and ever-greening provisions for biologics or drop it altogether."  CCPM Chair Annette Guarisco stated that coalition members "would rather have the status quo than legislation that guarantees profits for a few at the expenses of the American public."  In its release, the CCPM noted that a letter had been sent to Sen. Harry Reid (D-NV) and Speaker of the House Nancy Pelosi (D-CA), "urg[ing] lawmakers to resolve the current provision that will create an ineffective pathway to bringing biogenerics or biosimilars to patients and consumers," and "implor[ing] Congress not to overlook the immediate opportunity to bend the long-term cost curve of health care through a workable pathway for biogenerics."

The CCPM pointed to a recent Time magazine article (see "Time Magazine on Data Exclusivity Debate") as evidence of the "skepticism among the American public, pharmaceutical researchers, medical students, and industry economic experts about the results of BIO and PhRMA's influence on the health care reform deal."  The group also pointed to a paper in the New England Journal of Medicine (see "NEJM Authors Say Five Years of Data Exclusivity Would Be Sufficient"), which the CCPM contends "highlights the shortcomings of biologics provisions [in current health care reform legislation]."  In particular, the group says the article indicates that biosimilar legislation "would have no value because it would create a pathway that would scarcely be used," and further, "would allow for 'ever-greening,' or for manufacturers to obtain an additional 12-year exclusivity period by making minor changes to the structure of an approved product."  The group concludes that "[f]inding the right balance between incentives for innovation and timely access to care means that Congress needs to fix or drop the current biogenerics provision [in health care reform legislation]."

According to the CCPM website, the group has 33 participating members, which include Apotex, Hospira, Momenta Pharmaceuticals, Mylan Labs, Ranbaxy Pharmaceuticals, Teva Pharmaceuticals USA, Watson Pharmaceuticals, and the Generic Pharmaceutical Association (GPhA).

TJU Dean Asks Congress to Focus on Patient Safety

In a letter to the congressional daily The Hill, Dr. David Nash (at right), Dean of the Jefferson School of Population Health at Thomas Jefferson University in Philadelphia, PA, urges Congress not to ignore "the broader need of ensuring patient safety" when crafting a follow-on biologics (FOB) regulatory pathway in current health care reform legislation.  Dr. Nash, who last spring moderated a policy forum entitled:  "Regulation of Follow-on Biologics: Ensuring Quality and Patient Safety" at the National Press Club in Washington, DC (see "Follow-on Biologics News Briefs - No. 3"), noted that much of the FOB discussion has focused on the issue of data exclusivity.  He contends that "[t]his focus is extremely shortsighted, and ignores the broader need of ensuring patient safety for both current and future drugs."  Stating that "it is not possible to create an identical biologic copy of the original drug because of the living proteins and carbohydrates used to make them," Dr. Nash warns that "the complexity of the genetic engineering demanded for producing [follow-on biologics] creates serious safety concerns."  As a result, "[q]uestions of patient safety that hinge on the interchangeability and immunogenicity of FOBs can be answered only through rigorous and comprehensive human testing."  Dr. Nash also contends that FOBs should be subject to post-marketing study and surveillance.  He concludes that "[o]nly these actions can ensure that we're placing a higher premium on patient safety than other considerations."

Comments

[max hensley]

Very impressive effort by the Statists behind health care "reform." Not one stone remains unturned in the effort to buy votes for this disaster. The problem is that these products are going to be lopped off the Government formularies when budgets get tight as this thing really gets going in a few years, and then there will be 12 years of market exclusivity for no market.