Drug Pricing

Drug companies are pressing FDA to explain what its new "similar" category of biosimilars, which falls below the statutory "highly similar" measure, means for products that meet the lower bar, reacting to three new categories unveiled in FDA's draft biosimilar guidance on clinical pharmacology. The guidance's suggestion that immunogenicity data could be collected postmarket also has sparked confusion, with originator biologic makers urging FDA to require such data be gathered before biosimilars hit the market.

An emerging court battle over the generic drug Precedex, if successful, could arm branded drug companies with a way to block generic drug competition by preventing label carve outs with Orange Book patent listings, industry attorneys said. Hospira sued FDA last week after the agency approved generic versions of the company's sedation drug Precedex with labeling that carved out a patent-protected use; Hospira contends that the product's two uses overlap and the product is still under patent protection.

The global generic drug trade lobby may pull out of the International Conference of Harmonisation unless it gets a seat on ICH's standards-setting steering committee, which issues quality guidelines that affect biosimilar and generic drug companies, the lobby group warns in an Aug. 8 letter to ICH. The International Generic Pharmaceutical Alliance is upset that ICH in a recent meeting decided to shut the generic drug industry out the steering committee, which includes regulators and brand-name drug industry officials from major industrialized countries around the world.

As August recess draws to a close, a slew of House lawmakers within and beyond the Energy and Commerce Committee are drawing ideas from local constituents and key officials about medical innovation that could be included in discussions for the House 21st Century Cures Initiative. Rep.

A coalition of specialist physicians recently asked FDA to assign distinguishable names to biosimilar, saying National Drug Codes would not be a sufficient way for physicians to to track problems with these products. The physicians said many prescribers believe that shared nonproprietary names indicate the drugs are approved for the same indications, which might not always be the case for biosimilars, and any findings of interchangeabilty could become “moot” if all biosimilars share names with the reference product.

The Generic Pharmaceutical Association -- about a week before the World Health Organization formally unveiled a biosimilar naming proposal -- met with FDA to lay out its position, saying any change to the current system must apply to all biologics and retroactively, according to slides from the meeting. GPhA officials, lobbyists and several member company representatives met July 24 with Sally Howard, deputy commissioner for policy, planning and legislation, according to FDA records.

The health law's reductions in disproportionate share hospital payments may increase the importance of 340B drug discounts for some safety-net providers, but key policies surrounding the discount program remain in flux as the administration works internally to resolve issues that have long pit drug makers against safety-net hospitals, RAND Corporation says in an issue brief.