Regulatory Filings and Submissions

FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector.

The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

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

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.

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 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.

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

The agency launched a secure online portal for orphan drug designation applications.

FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.

Biosimilars and biobetters have their own unique manufacturing strategies and challenges.

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 FDA commissioner announced proposed steps to modernize the organization and functions of CDER’s Office of New Drugs.

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

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.

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 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.