Regulatory

While drug makers who sell insulin in the United States have had the past decade to prepare for the transition, stakeholders within the diabetes community must grapple with the potential impacts that this regulatory change could have.
Upadacitinib is expected to help AbbVie continue to lead in the immunology market after biosimilar competition emerges for adalimumab in 2023. The approval for the treatment of RA is one of 6 indications that AbbVie’s chief executive officer, Richard Gonzalez, said in a 2018 presentation that the company expects to have approved and launched by 2022.
Regeneron’s aflibercept (Eylea) has been approved by the FDA for a prefilled syringe (PFS) presentation. The 2-mg, single-dose, PFS will offer the greater ease of use less preparation than the vial presentation of the drug used to treat a range of eye disorders.
Instead of the “totality of the evidence” approach to biosimilars, authors of a new paper propose a “confirmation of sufficient likeness” paradigm.
The Center for Biosimilars® recaps the top stories for the week of August 5, 2019.
The International Generic and Biosimilars Medicines Association (IGBA), which represents generic and biosimilar medicines associations worldwide, recently released its report on how trade agreements can foster generic and biosimilar medicines and improve patient access to care.
The Center for Biosimilars® recaps the top stories for the week of July 29, 2019.
The first pathway for importation outlined in the plan would rely on a notice of proposed rulemaking to authorize importation of drugs from Canada. The second pathway would allow manufacturers to import versions of FDA-approved drugs that are sold in other countries.
July 2019 was a busy month for biosimilars on the regulatory front; not only did the FDA approve new products, but numerous policy proposals with a potential impact on biosimilar regulation were put forward by law makers.
The Federal Trade Commission (FTC) issued civil subpoenas to Johnson & Johnson (J&J) in June as part of an antitrust investigation into the contracting practices for the autoimmune drug Remicade, the originator infliximab sold by its Janssen unit, the company said in a regulatory filing on Monday.

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