Generic biosimilars get FDA and Congressional boost

Thursday was a good day for generic drugs, especially the biosimilar slice of that market, as the U.S. Food and Drug Administration issued draft guidelines for approval of biosimilars and, in a rare bipartisan moment, Republicans and Democrats on the House Energy and Commerce Committee pushed forward a bill to help give the FDA more money to speed the testing of all generics.

Most drugs are a combination of chemicals. Biologic or biotech drugs involve live molecules, either human or animal or both. Because biologic drugs are more complicated, more difficult to copy, more recently developed and often delivered via injection, the generic market has not reached the level it has with other drugs.

With budgets strained more by the minute, and everyone paying for drugs looking to spend less, generic biologic drugs are getting help. In 2008, the Congressional Budget Office estimated biosimilars could cut federal spending on biologic drugs by $25 billion over 10 years.

Beyond the complexity, the FDA did not have legal power to approve copies of biologic drugs until President Obama signed the Affordable Care Act in 2010 and Thursday's guidelines spin out of that.

“These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, in a statement. The agency will field 60-days worth of comments before finalizing its rules.

Generic biologic drugs are sometimes called biosimilars because the generic version is, according to the FDA, "a biological product that is highly similar to an already approved biological product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biosimilar and the approved biological product in terms of the safety, purity, and potency."

The Wall Street Journal published a chart using sales data from IMS Health, which listed the top 10 biologic drugs:

1. Humira, rheumatoid arthritis, $6.6 billion

2. Enbrel, rheumatoid arthritis, $6.5 billion

3. Remicade, rheumatoid arthritis, $6.4 billion

4. Avastin, cancers, $5.5 billion

5. Mabthera, non-Hodgkin's lymphoma, $5.4 billion

6. Lantus, diabetes, $5.1 billion

7. Herceptin, breast cancer, $4.5 billion

8. Neulasta, chemotherapy infections, $4.1 billion

9. Lovenox, deep vein thrombosis, $3.7 billion

10. Copaxone, multiple sclerosis, $3.6 billion

Total World-wide Biologic Market: $148.2 billion

*July 2010 to June 2011; Source: IMS Health

Just as patent holders of other drugs have exclusive periods to sell their product, biologic drugmakers will have 12 years without competition. Because of basic economics of supply and demand, it is during the period of exclusivity that manufacturers make the greatest profits. Generic companies will have demonstrate to the FDA that their product comes close.

“Sameness does not play a role in the determination here,” Rachel Sherman, director of the Office of Medical Policy in the FDA’s Center for Drug Evaluation and Research said, according to Bloomberg News. “It’s really how close” the copy is to the original, in terms of safety, purity and potency, she said.

Meanwhile, House members tried to codify the agreements (Biosimilars User Fee Agreement and Generic User Fee Agreements) struck between generic drug makers and the FDA into the Generic Drug and Biosimilar User Fee Act of 2012. Similar in form to its branded-drug cousin, the generic drug user fee will pay $1.5 billion over five years to help pay the tab for FDA testing and reduce the backlog of applications.

New Jersey Democratic Congressman Frank Pallone, Jr. said generics have saved $824 billion over the last 10 years.

“Generic drugs save lives at lower cost, but unfortunately the median time for a generic drug approval has doubled to 32 months,” Pallone said in a statement. “This bipartisan legislation will go a long way to giving the FDA the resources it needs to review these drug applications in a timely and effective manner.”

Republican Congressman Tim Murphy, whose district is south of Pittsburgh, said in a statement, “This historic legislation, based on an agreement between the FDA and the generic pharmaceutical industry, will allow us to bring less expensive therapies to market much more quickly. Less expensive drugs means improved access to care for patients, and that means fewer costly complications and hospitalizations due to untreated conditions."

The FDA press release is here.

The FDA guideline document for industry is here.

The Congressional Budget Office report on biosimilars is here.

Wall Street Journal story is here.

The Bloomberg News story is here.

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