Biosimilars & Generics
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Payors Take Lead From FTC In Suing BI Over Its Orange Book Patent Listings For Inhalers
Class action complaint alleges Boehringer Ingelheim engaged in a ‘Respimat Orange Book scheme’ to thwart generic competition for Combivent Respimat and Spiriva Respimat that cost payors millions, if not billions, in overcharges.
UK Competition Watchdog Attacks Tribunal As Hydrocortisone Fines Overturned
UK competition watchdog the CMA says it will be appealing against a tribunal decision that has overturned nearly £100m of fines imposed over anti-competitive deals around hydrocortisone, based on what the CMA criticized as a “fundamentally misconceived procedural point” linked to the cross-examination of witnesses.
Biosimilar Interchangeability Designation Would Be Nixed Under Biden Proposal
The proposal is not expected to cost or save the government money, but is expected to increase biosimilar uptake, according to budget documents.
Generics Group Urges Action On Licensing Delays As MHRA Unveils Guidance For Established Products
UK MHRA guidance outlining process changes aimed at shortening timeframes for assessing established medicines has been welcomed by the BGMA, which has emphasized the need to clear the regulator’s current approvals backlog that the association says is exacerbating shortages.
FDA-EMA Parallel Scientific Advice Program For Complex Generics Could Add Health Canada
Preliminary discussions are ongoing about adding Health Canada to the program intended to foster streamlined complex generic approval and increase access.
For Generics, EU Reference Product Is Non-Negotiable – Even In Pilot On Parallel Advice
Acknowledging that it may be a barrier to some extent, EMA’s senior scientific specialist of clinical pharmacology Kevin Blake notes that EU reference medicinal products are a legal requirement for bioequivalence studies and cannot be circumvented.
China Lowers GDP Target As VBP And Corruption In Focus At 'Two Sessions'
Amid slack domestic consumption and declining overseas demand, 2024 may be the start of a multi-year slowing in growth for the world’s second-largest economy. In the health sector, volume-based procurement continues to expand while the focus of anti-corruption campaigns appears to be changing.
European R&D Industry Warns SPC Proposals Could Cause Delays & Invite Abuse
A pre-grant opposition mechanism would introduce uncertainty into the existing supplementary protection certificate framework and would be open to abuse by third parties seeking to exploit gaps in the protection of originator drugs, according to EFPIA and the Chartered Institute of Patent Attorneys.
Mark Cuban: Pharma’s Secret Weapon In The Fight Against PBMs
The well-known businessman and TV personality told the White House that the US needs to ‘stop doing business with the big three PBMs,’ helping to fight the drug industry’s battle against the middlemen with a friendlier face not associated directly with the brand industry.
EU Biosimilar Filings, Opinions And Approvals
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
EMA Addresses Need For Guideline On Antivirals & MAbs For COVID-19
New EU guidance will cover non-clinical and clinical development, trial design, endpoints, safety issues and comparators, as well as the use of immunobridging studies.
Biosimilars: US FDA’s Updated Scientific Thinking Led To Interchangeability For Amgen's Wezlana
Pink Sheet’s Drug Review Profile explores Amgen’s Wezlana, an interchangeable biosimilar to Janssen’s Stelara. FDA determined late in the review that switching studies generally would not be needed for interchangeable ustekinumab products, prompting Amgen to seek the designation.
Two BLAs, One Suffix: FDA Diverges From Nonproprietary Naming Guidance For Amgen’s Wezlana
Assigning different suffixes to the prefilled syringe and intravenous formulations of Amgen’s ustekinumab biosimilar could create confusion and would not further the goals of the naming convention, the FDA said in explaining why it departed from its January 2017 final guidance.
Wezlana Chronology: From Biosimilar To Interchangeable In The Blink Of An Eye
Pink Sheet’s Drug Review Profile looks at the timeline behind the development and FDA review of Amgen’s Wezlana (ustekinumab-auub), an interchangeable biosimilar to Janssen’s Stelara.
French Agency Sets Up New Body To Advise On Biosimilar Substitution
The new committee, which will initially be in place for a year, will advise the French drug regulator when it is preparing its opinions on substitution in specific biosimilar product groups.
Pink Sheet Podcast: Price Negotiation Suit Tossed, Drug Shortage Probe, FDA-Approved Marijuana
Pink Sheet reporters and editors discuss the dismissal of PhRMA’s suit challenging the Medicare price negotiation provisions, the US FTC and HHS investigation of drug shortages, and the potential for FDA-approved marijuana products.
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