Biosimilars & Generics
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.

FDA Change In Bioequivalence Requirements Leads To Downgrade Of Accord’s Generic Tacrolimus
After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.

From Interchangeability To Invisibility: FDA Wipes Designation From Biosimilar Labels
Amid continuing stakeholder confusion over the meaning and significance of the US FDA’s interchangeability designation for biosimilars, the agency has now recommended omitting altogether details of interchangeability from biosimilar labels.
Drug Shortage Legislation: House GOP Finds Support For Bill While Dems Offer Concerns, Alternatives During Hearing
A proposed 340B rebate exemption for generic sterile injectables appears headed for the final drug shortage bill House Republicans are preparing, despite Democrats’ worries the idea could increase shortages.

FTC Set To Take Enforcement Action Against Drugmakers Over Orange Book Patent Listings
Merger reviews could take into account sponsor's Orange Book behavior. FTC's statement does not detail what would make a patent listing 'improper' but the precedents from court cases against various sponsors should offer industry some guideposts.

Biosimilar Clinical Trials: How Can Regulators Determine Waiver Early In Development?
The evidence is growing that comparative efficacy trials may not be necessary for all biosimilars, but regulators said they need a standard for sponsors to meet in order to waive them.

Pink Sheet Podcast: FTC Ends Amgen-Horizon Case, New Ultra-Rare Cancer Partnership, Generic Applications Lag
Pink Sheet reporter and editors discuss the US Federal Trade Commission ending its attempt to block the Amgen acquisition of Horizon Therapeutics, a proposed public-private partnership to develop ultra-rare cancer drugs, and a slow-down in ANDA submissions to the US Food and Drug Administration.

ANDA Submissions Lagging As FY 2023 Nears Its End
Generic drug sponsors are on pace to submit the second-fewest number of ANDAs in a fiscal year in the history of GDUFA.

Generic Drug Facility Post-Warning Letter Meetings Likely Will Hinge On ‘Reasonable Progress’
Facility owners should ensure they are ready when asking for the meeting on deficiency remediation because only two requests are allowed per warning letter.

Quotable: Top Experts On Policy Hot Topics
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Price Negotiation Purgatory: Upcoming Biosimilars Couldn’t Keep Stelara, NovoLog Off The List
Neither product counts as an ‘extended monopoly’ drug under the Inflation Reduction Act, meaning biosimilar entry cannot prevent Medicare from negotiating its price.

US FDA’s New Generics Chief: We Need More Flexibility For Complex Products
Iilun Murphy said Hatch-Waxman was written with immediate-release oral drugs in mind, not the complex generics becoming more popular today. The agency is evaluating the issue.

India’s Generics-Only Rx Rule: Not What The Doctor Ordered Or What Pharma Wants?
New norms call for generics-only prescriptions and prohibits doctors from engaging in third-party educational activity backed by pharma in India. Will pharma need to rethink its branded generics strategy in India or will questions about quality assurance sink the rules?

Complex Generic Sponsors Not Using US FDA-EMA Parallel Scientific Advice Program
After nearly two years, the program has received only two requests, driving FDA officials to try to boost interest.

Three Remain Liable On UK Liothyronine Price Abuse – But Fines Slimmed On Appeal
Advanz Pharma has failed in its appeal against a £40.9m fine imposed by the UK’s Competition and Markets Authority for its historical pricing practices for liothyronine tablets.

That’s So 15 Years Ago: Biosimilar Advocates Press US FDA, Sponsors To Evolve Thinking, Streamline Development
Requirements should adjust to scientific advancement, rather than remain rooted in times when the FDA and sponsors were inexperienced dealing with the products, sponsors argue.

Teva Pays Out $225m, Must Divest Pravastatin To Settle Criminal Price-Fixing Charges In US
Settlement with the US Department of Justice over criminal price-fixing charges includes donating $50m worth of medicines. Meanwhile, Glenmark has also struck a $30m settlement with the DoJ.
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Article
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.