Biosimilars & Generics

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.

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.

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.

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.

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 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.

Generic drug sponsors are on pace to submit the second-fewest number of ANDAs in a fiscal year in the history of GDUFA.

Facility owners should ensure they are ready when asking for the meeting on deficiency remediation because only two requests are allowed per warning letter.

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Neither product counts as an ‘extended monopoly’ drug under the Inflation Reduction Act, meaning biosimilar entry cannot prevent Medicare from negotiating its price.

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.

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?

After nearly two years, the program has received only two requests, driving FDA officials to try to boost interest.

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.

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.

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.