U.S. lawmakers revisit plans to approve biosimilars

Congressional lawmakers recently introduced two competing bills that would create an approval process for generic biopharmaceuticals.

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WASHINGTON—Unable to reach consensus on previous attempts to create a regulatory pathway for follow-on biologics in the United States, Congressional lawmakers last month introduced two competing bills that would create an approval process for generic biopharmaceuticals.

While Europe has established a regulatory framework to enable the approval of biosimilars, legislative discussions to do the same in the U.S. have failed to enact a standard approval process for generic biologics. The closest U.S. regulators have come to approving follow-on biologics is their handling of extremely small biologics such as human-made insulin and human growth hormone. The U.S. Food and Drug Administration (FDA) has barred other follow-on biologics from entering the market, contending that because biologics are genetically-engineered living cells, which are vastly more complex than traditional pharmaceuticals, their complexity is so great that there is no way to know whether or not a follow-on biologic is an exact copy. Meanwhile, both here and across the pond, patents on innovator products are expiring.

The bone of contention with lawmakers has been the length of time manufacturers of an original drug would be protected from generic competition. Although it takes $1.2 billion to develop an average biologic, and another $250-$450 million to construct the facilities necessary to produce it, the overall probability of success in clinical trials is only 30 percent. And even if a biologic reaches the market, it may not make money. Consequently, biologics must enjoy a longer period of data exclusivity than the five years granted for conventional drugs.

The two proposals introduced last month differ greatly on this issue.
The first bill, H.R. 1427, the "Promoting Innovation and Access to Life-Saving Medicine Act," was introduced March 11 by Rep. Henry Waxman (D-CA). The Waxman bill, which has seven co-sponsors, is based on the principles behind the 1984 Hatch-Waxman Act, which created an approval process for generic versions of chemical drugs. The bill, backed by several business and labor organizations, would give original biologic drugmakers an initial five years to market their drugs without generic competition and allow an extension of up to four more years.

The second bill, H.R. 5629, "The Pathway for Biosimilars Act," was introduced March 17 by Rep. Anna Eshoo (D-CA). H.R. 5629 would initially provide 12 years of exclusive marketing to original biologic drugmakers, which could then be extended by up to an additional 2.5 years. The measure has a whopping 54 co-sponsors and strong support from the pharma and biotech industries.

Steve Russek, chief clinical officer at Accredo Health Group, says the issue of exclusivity is "the final hurdle" a legislative proposal needs to clear in order to create a regulatory approval process for follow-on biologics in the U.S.

"I believe that in order to bring one of these drugs to the market, a very large investment is going to be required because these proteins are very complicated to create," Russek says. "I still believe there should be a margin in there that is much different than generics because with that level of pricing and investment, larger companies will need to believe there is still good investment opportunity there.

"From our point of view, we want to encourage manufacturers to create innovative solutions, and we also want them to have an exclusivity that allows them to recoup and make a profit," Russek continues. "On the other hand, when it comes to double-digit years, we're not able to get the savings for clients that we want to get. So in this case, we want manufacturers to make a follow-on biologic that can help reduce the costs to our clients."
The Waxman and Eshoo bills also differ on how to determine interchangeability, or the ability to substitute a follow-on for an original biologic at the pharmacy.

Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood says his group favors the Eshoo proposal because it will help protect patient safety by requiring demonstration of the purity, safety and effectiveness of biosimilars.

"Traditional pharmaceuticals are produced by machines and are relatively simple for generics makers to copy," Greenwood says. "Innovative biologics, on the other hand, are grown from living cells and are so molecularly complex that current science does not allow for an exact copy to be made, as the FDA has recognized. The fact that the medications are different calls for a slightly different set of rules around safety and competition incentives to achieve the same goals.

The proposals may also have to overcome a certain level of misunderstanding in the marketplace, Russek adds.

"The marketplace needs to have the right expectations," he says. "There are great differences between classic generics and follow-on biologics. Generics are very cheap, but biologics are still going to be expensive to produce."

No matter what fate these two proposals meet, Congress seems determined to make biosimilars a reality in the U.S. According to media reports, Sen. Edward Kennedy (D-MA) also plans to reintroduce his generic biologics bill from 2007 that would have allowed 12 years of exclusive marketing.

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