Patents and Generic Biologic Drugs- Part III of a III Part Series
We are separating the article on generic biologic drugs from the articles on patents on brand name drugs, since changes under the new health care law (Patient Protection and Affordable Care Act of 2010) allow for generic biologics.
(12/29/11)- Within the last three weeks, two of the leading biologic companies have announced alliances with generic drug companies in order to join forces in marketing biosimilar drugs that come off patent protection. As noted in our item dated 2/21/11, the new Patient Protection and Affordable Care Act limited patent protection for biological drugs to twelve years.
First came Biogen Idec's announcement that it would team up with Samsung to make and develop biosimilar drugs. More recently Amgen announced that it was teaming up with Watson Pharmaceuticals in a similar type of venture. In both these cases, the respective partnerships will not make generic versions of their own biological drugs.
Initially the biotechnology drug companies opposed any type of generic version of their drugs, since they claimed that since their drugs are made from living cells, unlike drugs made from chemical mixtures, the process could not be exactly replicated by generic versions of their medications.
Amgen and Watson will split the costs of development roughly in half, with Watson providing up to $400 million in cash or in-kind services. Watson would receive royalties and milestone payments on sales of the drugs.
Under the new law the Food and Drug Administration (FDA) is to develop rules for the approval of biosimilars. The agency has not released publicly any of its proposed new rules, so it will be quite a while before we see biosimilar generics for sale in the marketplace.
(2/21/11)- In President Barack Obama's proposed 2012 budget is a proposal to cut the patent exclusivity for biologics from 12 years down to 7 years. Thus, he would be revisiting the battlefield on this issue, since this was one of the planks in his 2008 presidential campaign.
The patent life for drugs is 20 years but the Patient Protection and Affordable Care Act of 2010 (PPACA) resulted in a 12 year patent protection period for biologic medications..
(2/8/11)- Although the Patient Protection and Affordable Care Act of 2010 (PPACA) provided for a 12 year patent protection for "biosimilar" drugs a controversy has arisen over the interpretation of the word "exclusivity" contained in the act.
The question is whether generic biotech companies have to wait the whole period of time before even beginning to seek approval, or can they start the process earlier, so that they are ready to market their product as soon as the 12 year period of time is up. The act was the vehicle under which biotech drugs first became patentable.
Senators John McCain (R.-Az) and Democratic Senators Sherrod Brown of Ohio, Tom Harkins of Iowa and Charles Schumer of New York sent a letter to the Food and Drug Administration siding with the generic drug companies on this issue. Earlier in January, 4 different senators sent a letter to the FDA siding with the patent holding biotech companies who claimed that "incentives for innovators to research and develop new treatments" dictate that the generic companies can not initiate the process until the patent expires.
A spokesman for Medicare said that the agency paid more than $2 billion for three anti-anemia biologics in 2009.
(11/10/10)- Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency are expected to set the rules, later this month, as what they will require before approving for sale "biosimilar" drugs. Under the provisions of the health care legislation that was passed this year, the makers of biological drugs are protected from generic competition for 12 years after they launch their product.
Unlike drugs that have a chemical makeup, biologics have proteins that can't be copied the way a chemical drug can be duplicated. Will that mean that a biologic generic will therefore have to undergo its own clinical trial before a regulatory body can approve it?
Once the rules have been set in all likelihood the matter than will have to go through the judicial process, before this matter finally gets resolved.
(7/29/10)- President Barack Obama's heath-care reform act that passed in 2010 allows the FDA to approve generic biologics to be marketed, with the FDA setting the rules as to what is required to gain approval.
The FDA recently approved the first generic version of the blood thinner Lovenox (enoxaparin) to be sold in this country. Lovenox, is manufactured and sold by Sanofi-Aventis SA, while the generic version thereof will be marketed by a subsidiary of Novartis AG.
Sanofi's subsidiary, Momenta indicated it may bring legal action to prevent the generic version of Lovenox to be marketed because the drug is too complex to be copied safely. Lovenox is drawn from animal proteins, and is in the middle of the categorization of a traditional chemical drug and a biologic drug which is made from human proteins.
(11/30/09)- Both versions of the proposed Senate health-care reform legislation and the House version of the legislation contain an approval process that allows generic versions of biologic drugs. In both houses the bills would prohibit generic-drug companies from competing with sales of brand-name versions of the biologics for at least 12 years.
Senator Sherrod Brown (Dem.-Ohio) said that he plans to fight to reduce the exclusivity period in the final bill, as well as "evergreening" provisos that may allow brand-name makers to extend the monopoly period by introducing slight changes to their product so as to gain extra exclusivity periods.
President Obama had proposed a 7-year period of exclusivity for biologics in his proposed budget back in February.
(11/3/09)- The proposed health-care bill that will be brought before the House shortly includes a provision creating a way for the Food and Drug Administration to approve generic versions of biologic drugs.
The proposed bill gives brand-name drug companies sales exclusivity for 12 years, and allows them to extend that time frame, with minor changes to their formulas.
(8/5/09)- You may ask why does a drug's market exclusivity period matter at all, since drugs are covered under patent protection for a period of 20 years. The problem arises because the FDA usually does not approve a drug for sale and usage until several years after the patent has been granted.
How big will the savings be, if generic copies can be made of patented biologic drugs. Biologic copies of generic drugs are called "biosimilar", not biologic generics because it is difficult, if not impossible to make an exact copy of a biologic drug. Remember that biologic drugs are made from live cells, and that means it is virtually impossible for a similar version thereof to be exactly the same.
Because even small changes might affect a drug's safety or interaction, biosimilar drugs would have to undergo their own expensive testing, and not be able to rely on the tests as is done on "small molecule pills". Since this can be a very costly process, it is estimated that a biosimilar drug could be sold at only about a 25% discount to the patented version of the drug.
In Europe, which has approved biosimilar versions of three biologic drugs, companies have priced these drugs at only a 20% to 30% lower price than the patented version of the drug.
The Congressional Budget Office has estimated that biosimilars might save the government only about $10 billion in the next 1 years. Biologics accounted for about $46 billion, or 16%, of total prescription drug sales last year, according to IMS Health, a market research firm. Also please keep in mind that pharmaceuticals accounted for only about 10 percent of the nation's overall health care spending last year, according to that same firm.
(7/25/09)- The Senate Health, Education, Labor and Pensions Committee voted to give biologics 12 years of market exclusivity. The White House had proposed 7 years. Representative Henry Waxman (Dem-CA), chairman of the House Energy and Commerce Committee favors only 5 years of market exclusivety.
Legislation expected soon from the Senate Finance Committee will leave out cost-cutting steps as part of an agreement with the industry and the White House, according to word that was leaked to the media.
Senator Edward Kennedy (Dem.-Mass.), who chairs the committee and also the state where many biologic companies reside introduced the 12-year proposal.
The biologic industry is growing at a rate of 18% a year and could hit $100 billion in sales by the year 2011. Other Democrats on the committee who strongly favor his proposal are Patty Murray (Dem-Wash.) and Barbara Mikulski (Dem-Md).
For more on this matter please see our item dated 4/2/09) below.
There are at least two items that are missing from the committee's proposal that also standout. The missing items include two planks of the Obama campaign platform: allowing cheaper drugs to be imported from Canada, and giving the federal government the right to negotiate Medicare drug prices with the drug companies on a centralized basis, instead of the present system wherein the Medicare Part D insurers individually negotiate drug costs with the drug makers.
(4/2/09)- Six senators have introduced legislation in the Senate, similar to Representative Henry Waxman's legislation in the House that we discuss in our item dated 3/16/09 below, that cuts the time allowed before generic versions of biotechnology drugs could compete with the originals to five years. Present law calls for a 12-year period of exclusivity for biologic drugs.
Senator Charles E. Schumer (Dem-NY) stated: "You have a new president, a new chairman on the House and most of all the need to cut costs to achieve national health care."
The bill would give the FDA the discretion to approve generic versions of biologic drugs with less extensive testing.
(3/16/09)- Representative Henry Waxman, the California Democrat who heads the House Energy and Commerce Committee has introduced a bill that would clear a regulatory path for generic drug manufacturers to produce generic versions of biologic drugs after a five year period of market exclusivity. He had introduced similar legislation twice before to no avail.
His bill is co-sponsored by Republican Nathan Deal of Georgia, who had previously opposed such legislation. Senator Charles Schumer, the New York Democratic Senator said that he would introduce similar legislation in the Senate shortly. Former Senator Hillary Clinton, who is the present Secretary of State was a leader while she was in the Senate in having this type of legislation enacted.
Unlike traditional drugs, which are manufactured by chemical interactions, biotechnical drugs are generally proteins manufactured in living cells. Makers of generic biologics must go through the same expensive and time-consuming clinical trials and other requirements that new drugs face. Regular generic drugs must only show bio-equivalency, and not have to undergo the expense of having a new clinical trial before getting the generic drug approved by the FDA for sale to the public.
The Waxman bill would set a five-year period of exclusivity, while the major biotech companies are hoping for 14 years of exclusivity. The Waxman bill does not state whether or not the generic drug makers would have to undergo clinical trials before gaining approval of their product from the FDA
A bill introduced in the House in 2007 from Rep.Joe Barton (R., Texas) and Rep. Anna Eshoo (D., Cal.) that was more favorable to brand-name biotech companies called for 12 years of exclusivity.
Please see:
Patents and Prescription Drugs-Part I
Patents and Prescription Drugs- Part II
FOR AN INFORMATIVE AND PERSONAL ARTICLE ON PRACTICAL SUGGESTIONS WHEN SELECTING A NURSING HOME SEE OUR ARTICLE "How to Select a Nursing Home"
By Allan Rubin
updated December 29, 2011
http://www.therubins.com
To e-mail: hrubin12@nyc.rr or rubin@brainlink.com