Diagnostic Kits/Glossary/Generics
From a DIYbio post about generics: (http://groups.google.com/group/diybio/browse_thread/thread/17414fa6b53cdf36/16c21e33b1402d86)
I didn't know that there weren't already generic biologics on the market. Silly me for assuming open competition as the default state in the medical industry. There's been advertisements (propaganda) on the radio (in Pennsylvania, at least) virtually every commercial break by the pharmaceutical industry asking people to tell their representatives to vote against this Brown-Schumer bill (for sake of "jobs", "high cost of research", and other spurious economic arguments).
Normally I'll be the first to dismiss the entire "absurdity and insanity of politics", but tissue cultures and bioprocessing for production of biologics are easily within domain of DIYbio and DIY H+ transhumanism / extropianism. Legal generics are a major step to popularly opening up availability of both knowledge and equipment towards those goals.
(I fully expect someone to be yielding and isolating significant quantities of PT-141 in their home laboratory within 10 years from now.)
http://en.wikipedia.org/wiki/Biologic
Biologics include a wide range of medicinal products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins created by biological processes (as opposed to chemically).
http://www.rollcall.com/issues/54_145/vested/35823-1.html
Biologics Battle Over Billions of Dollars Fight Fueled by FTC Report That Says 12-Year Exclusivity Unnecessary By Kate Ackley Roll Call Staff June 15, 2009, 12 a.m.
Lobbyists who want Congress to approve a swift pathway to generic versions of biotech drugs say the Federal Trade Commission last week handed their side a boost just as Congress wades into the health care reform debate.
But biotech brand companies, which have billions of dollars at stake, stepped up their own lobbying efforts, calling the FTC report flawed and working to give their side momentum on Capitol Hill.
“This study is an enormous game-changer,” said Mark Merritt, president of the Pharmacy Care Management Association, which supports a bill by House Energy and Commerce Chairman Henry Waxman (D-Calif.) that would give brand-name companies five years of market exclusivity for their biotech drugs before generics enterprises could market their versions.
Brand-name companies argue they need at least a dozen years of market exclusivity in order to make it worth their bottom lines to keep producing the products.
The FTC report stated that such a lengthy period of exclusivity was unnecessary.
The Senate Health, Education, Labor and Pensions Committee, which last week unveiled its health care reform bill, left out the details when it comes to biologics. Lobbyists for both sides say this week, when the committee is expected to mark up its bill, Senators will determine the length of exclusivity.
But on the House side, a competing bill to Waxman’s â one sponsored by Reps. Anna Eshoo (D-Calif.), Jay Inslee (D-Wash.) and Joe Barton (R-Texas) and generally supported by the brand industry â is adding co-sponsors.
“It blows apart this mythology that you need all these extra years of exclusivity to protect innovation,” added Merritt, whose group is part of the Coalition for a Competitive Pharmaceutical Marketplace. “This gives hope that there can be real biologics legislation that can provide real savings that can finance broader health reform.”
Biotech drugs, or biologics, are some of the costliest therapies on the market. They include such products as Genentech’s Herceptin, a cancer treatment, and Amgen’s Enbrel, which is used to treat rheumatoid arthritis. Biologics are almost never taken in pill form but are injected. And brand makers say they cannot be replicated exactly.
The debate is so contentious that even the terms are politically loaded. Brand makers use the terms biosimilars or follow-on biologics; Merritt’s side calls them biogenerics.
Tom DiLenge, general counsel for the Biotechnology Industry Organization, says his group is in favor of creating a pathway but needs a 12-year exclusivity. Otherwise, he said, “there would be much less incentive to engage in all of that work, if a competitor can free-ride on your work” immediately.
The brand-name side also says that the amount of money a quicker path to generics could save is not nearly as much as Merritt and his allies claim. David Beier, senior vice president of global government and corporate affairs for Enbrel’s maker Amgen, said that the most recent Office of Management and Budget report says the savings to the federal government would be about $6 billion over 10 years.
“People who claim that somehow there’s going to be a massive amount of savings, that just doesn’t work as a matter of mathematics,” Beier said.
But according to a draft letter from the Coalition for a Competitive Pharmaceutical Marketplace, “Growth in spending on biologics continues to outpace that of traditional pharmaceuticals, creating an ever-increasing multi-billion dollar savings opportunity for these life-saving products.”
The letter is expected to go to the Hill today, and its signers include consumer groups, unions and employers. The letter urges passage of the Waxman bill and a similar version in the Senate (S. 726) backed by Sens. Charles Schumer (D-N.Y.) and Sherrod Brown (D-Ohio).
A brand pharmaceutical industry source said the HELP Committee is considering three possible scenarios, including one that would give brand biotech drugs closer to 12 years of exclusivity and one that would provide far fewer years. (HELP Chairman Edward Kennedy [D-Mass.] sponsored a bill two years ago that provided 12 years of exclusivity.)
“Frankly, it’s in flux,” said this brand industry source. “There is some language that was circulated that troubles our industry quite a bit.”
Regardless of the number that comes out of the markup, the brands won’t stop there.
“The markup is only the first step,” this brand industry source said. “I don’t see it as being the end of the debate.”
Senate Introduces Bipartisan Bill on Biosimilars Apr 2, 2009 By: Patricia Van Arnum EPT--The Electronic Newsletter Of Pharmaceutical Technology
The US Senate introduced a bipartisan bill (S. 726) on Mar. 26, 2009, which establishes a regulatory pathway for approval of biosimilars. The bill, “Promoting Innovation and Access to Life-Saving Medicine Act'” was introduced by Senators Charles Schumer (D-NY), Sherrod Brown (D-OH), Susan Collins (R-ME), Mel Martinez (R-FL), and co-sponsored by other Senators. Last month, the House also introduced a bipartisan bill (HR 1427) for establishing a regulatory route for biosimilars.
A key provision in the Senate bill is to establish five years of market exclusivity for a biologic product from the time the brand-name drug was approved. The bill also establishes a procedure for resolution of patent disputes before a biosimilar is approved and establishes penalties for failure to litigate patents in a timely fashion.
“It’s past time we created a way for generic versions of these expensive drugs to come to market,” said Schumer in a press release. “We have a bipartisan plan that we know consumers will support and we believe the President will, too. The savings reaped from this will be a down payment on healthcare reform,”
The Biotechnology Industry Organization (BIO), the trade association representing biotechnology companies, was critical of the proposed legislation as it is with the House measure. “While well-intentioned, the bill introduced today by Senators Schumer, Brown, Collins, and Martinez follows its companion bill in the House (HR 1427, ‘The Promoting Innovation and Access to Life-Saving Medicine Act’) through the looking glass to a world of biosimilars that would jeopardize patient safety and undermine future medical breakthroughs,” said BIO President and CEO Jim Greenwood in a Mar. 26 BIO press release.
BIO disagrees with the time period allowed for exclusivity for brand-name biologics under the bill, the use of certain language that it says would discourage FDA from conducting certain clinical trials for a biosimilar, and information-disclosure requirements by biologics manufacturers.
“The bill unfairly tilts the playing field toward biosimilars manufacturers,” said Greenwood in the Mar. 26 press release. “This legislation provides for less data exclusivity than traditional pharmaceutical drugs currently receive under the Hatch-Waxman regime even though every credible study on this issue has found that biologics will need greater data exclusivity than traditional drugs to ensure future medical breakthroughs,” he said. “Additionally, innovators would be required under the bill introduced today to share detailed information about every applicable patent to biosimilar manufacturers, making it easier for the biosimilar company to bypass valid patents. Innovators, on the other hand, would have no ability to receive relevant information from the biosimilar manufacturer about the molecules, ingredients, and processes they use to create the biosimilar.”
Instead, BIO endorses another biosimilar bill, HR 1548, “The Pathway to Biosimilars Act.” That bill was introduced in March 2009 by Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA), and Joe Barton (R-TX). “The Eshoo-Inslee-Barton bill establishes parity with the outcomes of the Hatch-Waxman regime developed for traditional pharmaceuticals, balancing the need to increase access, lower costs, ensure drug safety and promote continued biomedical breakthroughs,” said Greenwood in a Mar. 17, 2009 BIO press release. “At the same time, the bill recognizes the fundamental differences between biologics and traditional pharmaceuticals.”
With regard to the Senate bill, Sens. Schumer and Collins said they are looking forward to moving forward with negotiations on the proposed biosimilar legislation as Congress considers broader health reform. In particular, they mentioned working with Sen. Edward Kennedy (D-MA), chairman of the Senate Committee on Health, Education, Labor and Pensions, to develop a pathway based on their legislation. In 2007, Kennedy was critical of a bipartisan group of senators that reached a compromise on generic biologics, according to the Senate press release. Several aspects of current Senate bill include measures from that compromise, including providing FDA full discretion to determine what studies are necessary to establish that a biogeneric is as safe and effective as the original product, said the Senate release.
http://blog.cleveland.com/openers/2009/03/sen_brown_floats_bill_to_allow.html
Sen. Brown floats bill to allow generic versions of biologic drugs Posted by Sabrina Eaton/Plain Dealer Washington Bureau March 26, 2009 17:33PM Categories: Sherrod Brown
Rule change could save seniors hundreds of dollars on prescriptions
Washington â Sen. Sherrod Brown joined a bipartisan crowd of U.S. senators today to announce a legislative compromise that would pave the way for the Food and Drug Administration to allow generic versions of biologic drugs that are produced from living cell cultures instead of chemicals. The senators said the FDA currently lacks the authority to approve generic forms of those drugs. The legislation Brown introduced with Sens. Charles Schumer (D-NY), Debbie Stabenow (D-MI), Susan Collins (R-ME), David Vitter (R-LA) and Mel Martinez (R-FL) would set up an FDA approval procedure. A bipartisan House of Representatives' counterpart of the bill has been introduced by Democrat Henry Waxman of California and Republican Nathan Deal of Georgia.
"We have seen what competition in the marketplace means," said Brown. "Generic drugs can save consumers hundreds of dollars a year . There's simply no reason we can't introduce the same kind of competition into a segment of the health care market where there hasn't been that kind of competition." Biologic drugs are often prohibitively expensive. For example the drug, Avonex, which treats multiple sclerosis, costs $20,000 yearly, even though its patent expired in 2003. Avastin, for colorectal cancer, costs $43,000 per course of treatment. Enbrel, which treats rheumatoid arthritis, can cost up to $25,000 per year. Allowing generic competition would bring down the drugs' price, the senators said, and save billions of dollars yearly for federal programs like Medicare and Medicaid.
The legislation is endorsed by groups, including the trade association for the nation's pharmacy benefit managers -- the Pharmaceutical Care Management Association -- whose president declared it would "increase access to life-saving medications, save billions and ensure continued innovation for new groundbreaking biologics."
It's one of those rare "win-wins" supported by consumers, "budget hawks," business, labor and policymakers on both sides of the aisle, the group's president, Mark Merritt, said in a press release.
The drug industry trade group Pharmaceutical Research and Manufacturers of America was less enthused. They issued a statement opposing the legislation on the grounds that the FDA procedures it outlines "are not sufficient to ensure patient safety." The group also dislikes that the bill would allow competition from generics after brand name drugs have been exclusively sold for five years, instead of 14 years, as the industry would prefer.
"Developing biologic cures is a complex and difficult undertaking," PhRMA Senior Vice President Ken Johnson said. "Congress needs to approach any changes in this arena carefully to safeguard the future development of life-saving and life-enhancing therapies."
Although similar legislation has been floated in previous Congresses, Brown predicts it will pass this time because it now has bipartisan support and is a priority of the current president.
"Competition brings prices down and causes more innovation," said Brown.