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Biosimilars & Generics

Set Alert for Biosimilars & Generics

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.

Generic Drugs Post Market Regulation & Studies

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.

Biosimilars Regulation

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.

Legislation Manufacturing

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.

Generic Drugs Enforcement

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.

Biosimilars Clinical Trials

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.

M & A Rare Diseases

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 Drugs Review Pathway

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.

Generic Drugs Manufacturing

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.

International Europe

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.

Biosimilars Medicare

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.

Generic Drugs Leadership

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?

Regulation India

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.

Generic Drugs Review Pathway

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.

Legal Issues Pricing Debate

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.

Biosimilars Clinical Trials

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.

Legal Issues Deals
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