They’ve had time to prepare.Facilitating the March 23, 2020, transition of approved marketing applications for biological products regulated under the Federal Food, Drug, and Cosmetic Act to be approved biologics license applications regulated under the Public Health Service Act (PHS Act). We look forward to hearing from our stakeholders over the 90-day public comment period for this proposal. This is exactly what happens. Approved biosimilars will be able to come to market, where there is incredible potential to reduce health care costs, as has been seen with increased generic drug offerings. Luckily, we still have about a year and a half left to plan for and execute the transition, but March 23, 2020 is rapidly approaching. The FDA has approved 15 biosimilars in the U.S., though none have gained the interchangeable status, a separate designation that regulators must grant.
It is hoped that this regulatory change will increase patient access and reduce costs for insulin therapies, which have been notoriously high in the US 3. Even having one generic drug on the market can reduce prices by 31%-39%, and biosimilars typically launch with initial list prices 15%-35% lower than the reference drug. FDA issued a draft guidance on March 14, 2016 explaining how the agency proposes to implement the provisions under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) for moving protein products currently approved under the drug statute (section 505 of the Food, Drug and Cosmetic Act) to the biologics system (section 351 of the Public Health Service Act). With respect to Orange Book listings – including patents and exclusivities for these products – the listings and the exclusivities will be terminated as of the transition date, except for orphan drug exclusivity.
As pharma makers come under fire by Congress for high insulin prices, FDA says it is stepping up efforts to increase competition in the category. The prescription kit from Conceivex, Inc., a medical device supplier in Michigan, is the only consumer product approved by the FDA and Health Canada for assisted insemination at home. It has a three-month supply of non-latex semen collectors, cervical caps made from implant-grade silicone, two dozen ovulation predictors and pregnancy test kits. A common ovulation-promoting drug known as Clomid can be prescribed separately for use with the kit to enhance chances of success further.
After this transition happens, it will be possible for manufacturers to submit, and the FDA to approve, marketing applications for biosimilar and interchangeable biological products that reference transitioned biological products,” such as insulin and other biological products such as human growth hormone (somatropin), pancrelipase, chorionic gonadotropin, follitropin alfa, and menotropins,” which will help ensure that the market is competitive, and patients may have more affordable access to the medications they need, said Dr. Yim.
Facilitating the March 23, 2020, transition of approved marketing applications for biological products regulated under the Federal Food, Drug, and Cosmetic Act to be approved biologics license applications regulated under the Public Health Service Act (PHS Act). This means that these biological products—including products like insulin—will be regulated under the PHS Act like other biological products and open to biosimilar competition. This, in turn, could lead to the development of more affordable biosimilar insulin products, including products that are interchangeable with branded insulins, without any compromise in safety and effectiveness.
Our Modern Diet Is Not Just Quick And Easy
This may be good news for partners Mylan and Biocon : Two bills are circulating on Capitol Hill that can alter the transition of insulins to biologic agents in March 2020. The final rule, Definition of the Term ‘Biological Product,’” amends the FDA’s regulation that defines biological product” to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020, and to codify the FDA’s interpretation of the statutory term protein.” Under this interpretation, the term protein” means any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. This interpretation is intended to clarify the statutory framework under which such products are regulated.
The classified report on biological warfare in the story is fictitious (at least none has been disclosed) but the government reports cited from scientists at the FDA, EPA and USDA reporting GMOs as unsafe and calling for toxicology reports and further testing are real, having been accessed through litigation using the Freedom of Information Act, and you can read them on the Internet. Arpad Pusztai is a real scientist, who conducted the first experiments on lab rats, and whose work was severely discredited until the UK government found out the real truth; that it had rushed into early approval of GMO foods and its ministers had hired Pusztai to do the study in two weeks, after already having approved GMO foods for public consumption.
Mulcahy believes some product makers have delayed putting their biosimilars on the market because of an aggressive patent litigation strategy by biologic makers and regulatory questions over issues such as interchangeability; the FDA determines if a biologic is interchangeable, or can be switched out for a biosimilar with no significant therapeutic risks. So far, the FDA hasn’t designated any biosimilar as interchangeable with a brand-name biologic reference drug.
At the surface, this legislative change seems tiny- unless your firm is producing a chemically synthesized polypeptide product. If you are such a firm, this change is not tiny to you as your product will now be part of the March 2020 transition from NDAs to BLAs, potentially with all of the associated consequences. These changes are not trivial- they include a new CMC review office, a greater emphasis on process microbiology, a new team of pre-approval inspectors and the need for upfront process validation in the BLA.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Yet, a small subset of biologics—including insulin and human growth hormones—historically had been approved under the statute for drugs, the FD&C Act. Because these biologics were not approved under the PHS Act, sponsors could not seek approval of biosimilars or interchangeables of these products under the BPCIA. That will change on March 23, 2020, however, when all biological product” applications approved under the FD&C Act will transition” to being regulated by the PHS Act.