When Will We Have the Option of Generic MS Self-Injectable Drugs? (March 25, 2008)
Generic Biotech Drugs -- The House Energy and Commerce Committee meeting to consider establishing a Regulatory Pathway for Follow-On Biologic Drugs (October 24, 2007)
Today, Gooz News published the following article which addresses a significant difference which proposed legislation will have on patients using expensive biological drugs, such as the MS disease-modifying drugs.
The debate over a regulatory pathway for biotechnology generic drugs is shaping up and it doesn’t look good for cost-conscious patients or anyone pulling their hair out over rising health care costs.
Last week, both Merck and Eli Lilly announced plans to expand their biotechnology divisions. While they are taking aim at proteins already on the market, both companies told the press that their new biotech drugs would not be generics in the traditional sense. They will be slightly modified versions of existing drugs that will be run through the full panoply of clinical effectiveness testing and sold at prices much closer to the original drug.
In essence, both companies are banking that the “biosimilar” legislation that now seems destined to pass Congress next year will bring into existence a biotechnology me-too industry. That’s very different than a true generic industry, which was created by the Hatch-Waxman Act of 1984 for traditional drugs.
Unlike true generics, which are exactly like the original drug, me-too drugs contain slight modifications that qualify for their own patent protection. Their clinical usefulness may be no different or only slightly improved from the original. But, because they have been put through their own clinical trials and have patent protection, they can be marketed to physicians as unique products and priced accordingly.
The results are often of marginal benefit to patients, consumers and health care plans. Me-toos are usually priced within 10 to 20 percent of the original drug’s price, and sometimes cost more if they have marketable benefits like less frequent dosing. True generics, on the other hand, usually cost less than half of the original molecule because multiple firms jump into the fray and there is no direct-to-consumer or direct-to-physician marketing to inflate costs.
Read the remainder of the article at Gooz News which ends with this:
Clearly, it’s going to take a lot of consumer and payer pressure to get legislation that offers fast and meaningful economic relief from the high cost of biotech drugs when their patents expire. Changes in patent law to enable a me-too biosimilar industry isn't even half a loaf. What the public needs is a pathway to biogenerics that doesn't require costly, duplicative clinical trials.
I've not been keeping up with recent developments, but it's time to get back into following pharma and congress.