2012 Biosimilars Labelling 
FDA Law Blog: Biosimilars
JANUARY 9, 2025
Although FDA has long taken the position that it has broad authority in how it conducts its inspections, it was not until 2012 that Congress put some teeth behind FDAs policy position. to take photographs as necessary; to collect samples; talk to pertinent staff ; or to collect food labels and labeling).
FDA Law Blog: Biosimilars
JANUARY 12, 2025
Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).
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Safe Biologics
MARCH 21, 2024
From the Executive Summary: The ASBM has supported the INN Group’s Biological Qualifier (BQ) scheme since its inception in 2012, and since then has doggedly presented data on the importance of a BQ to enhancing patient safety and pharmacovigilance (PV). However, most of them are willing to support a WHO system if it is implemented.
European Pharmaceutical Review
JULY 4, 2024
However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 2 It was first approved as Fulyzaq in December 2012 and in October 2016, Napo Pharmaceuticals launched the new brand, Mytesi. 2012/1916). 3 Is two too few? Ethnopharmacol.
FDA Law Blog: Biosimilars
APRIL 30, 2023
112-144 (2012). As background, FDC Act § 505(q) states that FDA shall not delay approval of a pending ANDA, 505(b)(2) application, or 351(k) biosimilar application as a result of a citizen petition submitted to the Agency pursuant to 21 C.F.R. 110-85 (2007), as amended by Section 301 of Pub.
Safe Biologics
MAY 10, 2024
Biden Administration HHS Budget Would Permit Third-Party Substitution of All Biosimilars On March 11th, the Biden Administration released its FY25 HHS Budget. and Europe alike, prescribers can already substitute any biosimilar for its reference product. Currently there are 10 biosimilars that can be substituted by U.S.
PharmaShots
APRIL 13, 2023
Johnson & Johnson delivered solid results in 2012 with profitable growth due to their top and newly developed products that lead to a revenue of $67.2B. The company faced a tough time in 2019 as the first biosimilars for its best-selling drugs (Rituxan, Avastin, and Herceptin) emerged.
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