Regulatory Authority Actions

 FDA approved Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. The approval is a groundbreaking decision, as Sandoz is the first pharmaceutical company to have a biosimilar product approved in the United States. Known as Zarzio outside of the US, Sandoz says its biosimilar filgrastim is already available in more than 60 countries worldwide, has generated more than 7.5 million patient-days of exposure, and is "the most widely used filgrastim in Europe."

A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.

Scientists and industry experts seek effective preventive therapies to combat global disease.

A new technical report guides bio/pharma companies in establishing a risk-based approach for prevention and management of drug shortages.

FDA announced that it would postpone a meeting that would be critical for the advancement of Celltrion’s Remicade biosimilar in the US.

The company voluntarily recalls product due to FDA observations of potential sterility problems.

Drug shortages are declining, but they’re still a serious concern for regulatory authorities, policy makers, and bio/pharmaceutical manufacturers.

The agency cites Apotex’s Bangalore facility with quality system failures.

The agency is enlisting members of European pharmaceutical associations and industry representatives to participate in IDMP task force.

The draft guidance contains policies for drugs that are processed with additional manufacturing steps such as remixing, dilution, and repackaging.

FDA announced that it approved Lenvima to treat patients with differentiated thyroid cancer after it was submitted under a priority review and orphan drug programs.

The agency releases five draft guidance documents related to drug compounding and repackaging.

FDA gives an update on currently approved Risk Evaluation and Mitigation Strategies.

The National Institute for Health and Care Excellence released an updated version of its biosimilar approach guidance, including increased consideration for technology appraisal, references in documentation, and the production of “evidence summaries”.

The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality.

The industry reacts to the departure of Commissioner Margaret Hamburg.

On February 3, 2015, the FDA published a notice in the Federal Register that it is soliciting input on the collection of data to support interchangeability claims in biosimilar applications.

FDA has approved Genetech’s Lucentis to treat retinopathy in patients with diabetic macular edema.

The agency releases guidance documents on Individual Patient Expanded Access Applications and disclosing risk information to patients.

Margaret Hamburg announced on Feb. 5, 2015 that she will step down as FDA Commissioner after serving in the position for almost six years.

FDA releases a Q&A with the Drug Shortage team leader from the Center for Drug Evaluation and Research.

The cyclin-dependent kinase 4/6 inhibitor for the treatment of metastatic breast cancer was approved more than two months ahead of the prescription drug user fee goal date.

The 2016 White House Budget proposes a change to the data exclusivity period for biologics and the authority to influence drug pricing.

FDA says it is “weighing the appropriate regulatory approach” to handle the tasks outlined by President Obama’s new Precision Medicine Initiative.

Manufacturers face new rules for tracing drugs through the supply chain and compounders face stricter standards.

EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.

Bristol-Myers Squibb and Johnson & Johnson announced FDA-approval of Evotaz and Prezcobix, combination HIV-1 infection treatments.

Dr. Robert Califf is appointed FDA Deputy Commissioner for Medical Products and Tobacco.

The agency creates an electronic central repository to facilitate drug safety assessment reports.

FDA guidance discusses factors to consider in evaluation of photosafety and describes nonclinical photosafety tests.