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Nov 14, 2024 | 
jdsupra.com | Deborah Cho |Jason Conaty
FDA recently announced final guidance on “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms,” as well as Q&A guidance of the same name, which provides recommendations on conducting bioequivalence (BE) studies during both development and post-approval phases for orally administered immediate-release (IR) solid oral dosage forms that are designed to deliver drugs to systemic circulation, such as tablets, capsules, and granules/powders for oral suspension.
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Aug 30, 2024 | 
jdsupra.com | Deborah Cho |Jason Conaty |Komal Karnik Nigam
This is the fourth comment related to the pharmaceutical industry the FTC has submitted to various agencies since the beginning of 2024, and part of a broader effort by the FTC to prioritize “safeguarding fair competition and rooting out unlawful business practices in health care markets.”[1] Under the Public Health Service Act, the standard for interchangeability is that a biosimilar “can be expected to produce the same clinical result as the reference product in any given patient.”[2] For a...
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Aug 29, 2024 | 
lexology.com | Philip Katz |Chuck Loughlin |Gary Veron |Komal Karnik Nigam |Ilana Kattan |Jason Conaty | +3 more
This is the fourth comment related to the pharmaceutical industry the FTC has submitted to various agencies since the beginning of 2024, and part of a broader effort by the FTC to prioritize “safeguarding fair competition and rooting out unlawful business practices in health care markets.”[1] FTC says FDA’s Draft Guidance on interchangeability will increase competition in biologic marketplaces Under the Public Health Service Act, the standard for interchangeability is that a biosimilar “can...
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Aug 7, 2024 | 
jdsupra.com | Jason Conaty |Ashley Grey |Randy Prebula
“Combination products” are comprised of two or more different types of products (i.e., a combination of a drug, device, and/or biological product).
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Aug 7, 2024 | 
lexology.com | Randy Prebula |Jason Conaty |Eva Schifini |Ashley Grey
The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision modernizes the guidance to align it with current user fee program expectations.
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May 24, 2024 | 
jdsupra.com | Deborah Cho |Jason Conaty |David Fox
Under the Biologics Price Competition and Innovation Act (BPCIA), a “biosimilar” product is one that is demonstrated to be “highly similar” to the reference product with “no clinically meaningful differences [from the reference product] in terms of the safety, purity, and potency of the product.” “Interchangeability” requires a product to not only be biosimilar to its reference product, but to also be “expected to produce the same clinical result as the reference product in any given patient”...
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May 23, 2024 | 
lexology.com | Deborah Cho |David Fox |Jason Conaty |Komal Karnik Nigam |Will Tenbarge
The U.S. Food and Drug Administration (FDA) recently released a podcast on biosimilars, featuring Dr. Sarah Yim, director of FDA’s Office of Therapeutic Biologics and Biosimilars (OTBB), that seems to indicate a potential move away from differentiating non-interchangeable biosimilars and interchangeable biosimilars.
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May 7, 2024 | 
jdsupra.com | Jason Conaty |David Fox |Ilana Kattan
The new warning letters are the latest salvo in the FTC’s expanded “campaign against pharmaceutical manufacturers’ improper or inaccurate listing of patents” in the Orange Book.
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May 6, 2024 | 
lexology.com | David Fox |Philip Katz |Chuck Loughlin |Gary Veron |Jason Conaty |Ilana Kattan | +2 more
On April 30, 2024, the Federal Trade Commission (FTC) announced that it sent a new set of warning letters to ten pharmaceutical companies. The letters inform the companies that the FTC has notified the Food and Drug Administration (FDA) that the Commission is disputing 300 allegedly “improper or inaccurate” patent listings in the FDA Orange Book.
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Jan 10, 2024 | 
jdsupra.com | Jason Conaty |David Horowitz
On January 5, 2024, the U.S. Food and Drug Administration (FDA) authorized Florida’s proposal under the Section 804 Importation Program (SIP) to allow Florida to proceed to the next steps in the regulatory process to import certain drug products that were approved by Health Canada. FDA’s authorization represents the Agency’s determination that the proposal meets the statutory standard for significant cost reduction without posing additional risk to health and safety.
