Biosimilars & Generics

The development could highlight the power of competitive market forces over government price controls or suggest Medicare price negotiation is enhancing competitive market forces.

Roche is in the crosshairs of the Belgian Competition Authority for allegedly delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices.”

Two recent disclosures from Xbrane Biopharma and Formycon demonstrate the evolving US Food and Drug Administration thinking about the need for Phase III trials to support biosimilar filings.

Regulatory authorities from multiple regions are considering extending a pilot project related to collaborative assessments of post-approval chemistry, manufacturing and controls changes, with a focus on the supply of critical medicines.

Teva was forced to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March after the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?

Multiple sources, including former Acting FDA Commissioner Janet Woodcock, told the Pink Sheet that industry is quietly complaining about FDA work delays and they expect the problem will worsen.

The FDA generic drugs team’s first public workshop of the second Trump Administration ended with a request that industry amplify the value it finds from public engagement.

Unofficial January results showed the US FDA continued to issue full and tentative ANDA approvals in line with previous months, but recent layoffs may not help the agency maintain that pace.