This is really a touchy situation, we want drugs that works and for a price where we can all afford.  One way or another it appears it’s going to come about but when and what the stipulations are remain to be one big gray area.  Merck for one is getting set up with one recent purchase to enter the Bio Similar market.  Right now Merck and Teva are in legal battles over the patent on Singulair, as the validity of the patent is being questioned.  I would guess there’s probably nothing wrong with the patent, but it might be more of an issue of timing.  We are at a time when health care costs are going through the ceiling and the challenge is there because it can be and an agreement to allow a generic to be produced before the original patent time could emerge, again, as Merck may get tired of the legal battle and settle, again this is just something that could occur, due to timing and the demand for affordable drugs.  

“The terms "Biosimilar" or "Follow-on Biologic" refer to products that are marketed after expiration of patents, which are claimed to have similar properties to existing biologic products. Due to the complexity of biologics, a product can only be made that is similar, but not identical.”

It’s basically coming down to what we have been fighting in healthcare, who’s going to pay the bill, except in this case, who’s going to pay for the R and D?  Biotech drugs are much more complicated and the time to develop is even more so, ask Genentech for one.  

The problem with biotech is that it is complicated and not understood and that includes Congress as well as the rest of us.  Another blog put it this way:

"The biotech industry deals with an ongoing basic education challenge: that our industry is not well-understood," says Gardner. "The science behind biotech is not well understood—the process of going through basic research to clinical trials to successfully delivering a product to patients worldwide. It's incredibly complicated, it takes a long time, and we have to show that process to elected leaders."

“In 2000, Trull's firm was engaged by a New Jersey biotech called Anthra (which has since been sold and disbanded) that had a compound designed to treat bladder cancer which had been voted against, by a count of 14-0, by an FDA advisory panel. Trull's team determined that not one member of the advisory panel had expertise in the subject matter. They took the issue to a New Jersey member of Congress, who then brought up the issue with the FDA. The federal agency agreed with the criticism, and added a knowledgeable person to the panel. The product was reconsidered and approved for market.

Often, "technology gets ahead of the regulatory pathways," says Trull. "The FDA is always confronted with these kinds of challenges, and this is where lobbying really matters," she adds.”

Here’s one example of a bio-similar that was rejected by the FDA last year:

The FDA have given a thumbs down to Genzyme's request for permission to sell its Pompe disease drug Myozyme manufactured in an Allston, MA plant. Genzyme is already manufacturing the drug in a smaller Framingham-based plant and wants to ramp up production at the larger Allston location. But the FDA ruled that the Allston-produced Myozyme must "be classified as [a different product] because of differences in the carbohydrate structures of the molecules." The FDA said Genzyme has to submit a separate BLA to gain approval for Myozyme produced on a larger scale.

This blog above talks about lobbying, but much in part of what is emphasized is education, so if we could lobby without politics and just focus on educating Congress and their aides, things might go a little smoother, after all we would hate to have a huge potential heart disease biotech drug over looked for one that helps cure baldness, but it happens.  I actually used that comparison as spoken recently by Bill Gates. 

The FDA had to find members with experience for their advisory panel, so perhaps we can use some of the same in Congress, some actual scientists as aids to work with and advise them, with a non partisan approach. It appears much of the R and D is leaving our shores for cheaper ground right now and we either have to compensate less here to bring cost down a bit,  or accept what is delivered in technology from outside our borders, and there’s not much in between.  We are not the only country in this scenario, but probably the largest with the most at stake. 

I read an article this week that was titled “China is the next Israel, so where does that leave Israel?”, maybe something we might ponder here as well.  BD

WASHINGTON (AP) — Biotech drugs that now cost thousands of dollars per month would have to compete with lower-cost generic versions after just five years on the market, under a new congressional proposal.

The bipartisan bill introduced Thursday is the latest salvo in a years-long effort to lower the price of biotech drugs, high-tech injectable medications that cost the nation more than $40 billion per year.

The proposal from Sen. Charles Schumer, D-N.Y., and Susan Collins, R-Maine, suggests generic drugmakers are gaining traction for their long-sought goal: a speedy, low-cost pathway to market for generic biotech.

Biotech drugs, such as the blockbuster cancer drug Avastin, currently don't face generic competition because the Food and Drug Administration doesn't have power to approve copies of such medications. Efforts to change that have been held up for nearly a decade by squabbling between the biotech and generic drug industries and their allies on Capitol Hill.

The Pharmaceutical Research and Manufacturers of America warned Thursday that a shortened exclusivity period could discourage companies from investing in drug development, jeopardizing new medicines and "high-quality, science based jobs."

"Developing biologic cures is a complex and difficult undertaking," said a statement from the group. "Congress needs to approach any changes in this arena carefully."

The European Union has been approving generic biotech drugs since 2006, with 11 years of exclusivity for original products.

The Associated Press: Generic biotech effort picks up steam in Congress

Related Reading:

Here Come the Bio Similar Drugs – Bill in Congress to allow Follow Me Provisions for the FDA

Merck Purchases Insmed – Biosimilar Biotech Drug Company
Pfizer Joins the Generic Club
Genzyme gets biosimilar rejection

Biotech Campaigns for Easier Access to Generic Drug Market - Can we put the decision making process back in the hands of the clinicians..and what about biosimilars...

Genzyme gets biosimilar rejection


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