Regulatory Filings and Submissions

The European Commission (EC) approved Pfizer’s Trazimera (trastuzumab), a biosimilar to Roche’s Herceptin, to treat certain breast and gastric cancers.

More consistent and reliable production processes are critical for advancing innovative treatments.

The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.

A published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.

Managing data at the different stages of the lifecycle, linking disparate systems together, and making the right data available to those who need it is problematic and time consuming.

The agency has approved Tpoxx (tecovirimat), the first drug with an indication for the treatment of smallpox, to address the impact of a potential outbreak.

New FDA guidance suggests ways to supplement labeling, to ensure that patients select and use nonprescription drugs safely.

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

The European Medicines Agency recommended Novartis’ Kymriah (tisagenlecleucel) and Kite’s Yescarta (axicabtagene ciloleucel), chimeric antigen receptor (CAR) T-cell therapies, for approval in the European Union.

The agency published guidance on how the Generic Drug User Fee Amendments Reauthorization of 2017 applies to amendments to ANDAs and PASs.

GW Research’s Epidiolex, which treats two forms of epilepsy, receives FDA’s approval; spurs FDA reminders about unapproved products.

The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.

The approval is intended to increase patient access to treatment for opioid addiction.

FDA Commissioner Scott Gottlieb, MD, released a statement on new agency efforts to involve the patient voice in medical product development and FDA regulatory decision-making.

The agency is encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.

The agency has approved Mylan’s Fulphila (pegfilgrastim-jmdb) as the first US-approved biosimilar to Amgen’s Neulasta (pegfilgrastim) to reduce infection risk during cancer treatment.

The agency has recommended approval of three biosimilar adalimumab products from Novartis, referencing AbbVie’s Humira, and a biosimilar trastuzumab from Pfizer, referencing Roche’s Herceptin.

EMA has recommended marketing authorization for Aimovig (erenumab), a new treatment for migraine.

The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.

The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.

The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson’s blockbuster Remicade (infliximab).

Right-to-Try bill sent to White House for President’s signature after passage by Congress.

The new drug offers rapid and sustained control of patients’ potassium levels.

The agency approved Amgen and Novartis’ Aimovig (erenumab-aooe), the first FDA-approved preventive treatment for migraine in adults.

The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.

The agency has approved Retacrit (epoetin alfa-epbx) by Pfizer’s Hospira, which is a biosimilar to Amgen’s anemia drug, Epogen/Procrit (epoetin alfa).

Barriers impede biosimilar market entry into the United States despite the Biologics Price Competition and Innovation Act.

The use of more targeted therapies is expanding as the public gains access to low-cost genetic testing, and more advanced computer systems are offering data from healthcare systems.

The agency is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for violating cGMP requirements.

Pharmaceutical companies should consider what is required for QIDP designation and whether they can use it to extend the protection afforded to their innovative products.