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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
A bipartisan bill that would establish a regulatory pathway for the approval of biosimilars was introduced into the US House of Representatives last week.
A bipartisan bill that would establish a regulatory pathway for the approval of biosimilars was introduced into the US House of Representatives last week. The bill (HR 1427), “Promoting Innovation and Access to Life-Saving Medicine Act” was introduced by Reps. Henry Waxman (D-CA), Frank Pallone (D-NJ), Nathan Deal (R-GA), and Jo Ann Emerson (R-MO).
Under the proposed legislation, the US Food and Drug Administration would be authorized to approve abbreviated applications for biosimiliar and biogeneric (or interchangeable) biologics products. The application for a biosimilar must demonstrate to FDA that there are not clinically meaningful differences between the biosimiliar and the original product. The applicant must also show that the two products are highly similar in molecular structure and share the same mechanism(s) of action, if known.
Under the bill, an applicant for a biosimilar may also try to establish that the product is biogeneric or interchangeable with the original biologic product. The bill specifies that a product found by FDA to be interchangeable can be safely substituted for the original product if state law permits. The bill grants six months of exclusivity to the first applicant to demonstrate interchangeability to FDA.
The bill also would provide FDA with full scientific discretion to determine what clinical studies are needed to establish that a biosimilar is as safe and effective as the original product or that a biogeneric is interchangeable with the original product. The bill would allow FDA to require additional clinical studies in both instances. FDA would also be allowed to require postmarket safety studies for biosimilars and biogenerics. The bill further establishes user fees for companies that file applications for a biosimilar product.
The proposed legislation would also allow an applicant to submit an abbreviated application for a product that differs from or incorporates changes to the original product if the application contains sufficient information to show that the new product is “safe, pure, and potent [safe and effective],” according to the bill.
Initial exclusivity for an original product with a novel molecular structure would be entitled to five years of exclusive marketing. A modification of a previously approved product is entitled to three years of exclusive marketing in certain instances, according to the bill. The bill would allow these periods to be extended by up to one year if the applicant establishes that the product can be used for a new disease indication or conduct pediatric studies. The bill also establishes a procedure for resolution of patent disputes before a biosimilar is approved and establishes penalties for failure to litigate patents in a timely fashion.
“I believe this bill will lead to healthy competition and long-term savings for patients and payers, and will preserve innovation in the biotech marketplace,” said Waxman in a House Energy and Commerce Committee press release. “Above all, this bill guarantees that FDA has the scientific discretion to hold these drugs to the same high standard to which the original products are held. The only way we can succeed in establishing robust competition for biotech drugs is with biosimilar drugs that doctors and patients know they can count on.”
Sens. Charles Schumer (D-NY), Susan Collins (R-Maine), Sherrod Brown (D-OH), and David Vitter (R-LA) are expected to introduce a bipartisan companion bill in the Senate in the near future, according to the House press release.
The Biotechnology Industry Organization (BIO), the trade association representing the US biotechnology industry, voiced his opposition to the bill. “This bill seeks to cut prices but instead cuts corners,” said Jim Greenwood, president and CEO of the Biotechnology Industry Organization, in a BIO press release. “This proposal leads us off the map as we seek an effective, fair, and safe pathway to a biosimilars market.”
“Parity between the generic drug regime for small molecules and a pathway for approval of biosimilar drugs is desirable and can be achieved,” said Greenwood. "However, parity must focus on the outcome of the respective pathways and not be distracted by superficial similarities. A pathway must recognize that biologics are much more complex than traditional pharmaceuticals and that the regulatory standard for approval of biosimilars will be based on similarity rather than sameness as is the case with traditional generic drugs. As the US Food and Drug Administration has noted, biotech drugs are so molecularly complex that they are almost impossible to map accurately with existing science. Even minor differences in the purity of a biotech drug can change its efficacy and safety. We can take no short cuts to safety when it comes to biosimilars.”