Regulatory Filings and Submissions

NICE announces plans to back biosimilar alternatives to Merck’s Remicade.

On Jan. 27, 2016 FDA announced it plans to review Merck’s investigational antitoxin prevention bezlotoxumab.

More “me-betters” and more focused breakthroughs could enhance new drug development.

The agency has published draft guidance on safety assessment for investigational new drug application safety reporting.

FDA approves Kanuma, the first treatment for patients with lysosomal acid lipase.

FDA sets a July 2016 deadline for the final version of the rule on labeling changes for approved drugs and biologics.

FDA confirmed quality focus while Congress moved to bolster biomedical innovation.

There’s renewed optimism in the biomedical research community that years of effort finally may begin to pay off for developing cutting-edge gene and cellular treatments for debilitating and life-threatening conditions. Jill Wechsler reports.

All biosimilars for a specific product will be reimbursed with the same J-code under Medicare Part B regardless of manufacturer, according to a CMS rule that was proposed in July 2015 and finalized on Oct. 30, 2015. The rule was finalized prior to any formal guidance from FDA on interchangeable products.  CMS said it did not consider interchangeability into its decision, as there are no currently approved interchangeable biologics on the market.

The agency issued a draft guidance document on the requirements for submission of applications for liposome drug products.

The agency gives an update on the regulation of combination medical products.

In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.

The company adds a few new arguments-as well as new stakeholder support-to its Citizen Petition on biosimilar naming.

Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.

An advisory panel deemed Amgen’s Repatha (evolocumab) to be safe overall.

The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

Physician confidence in biosimilars and extrapolation of indications are two of the most important factors governing the acceptance and sustainability of biosimilars, say industry panelists.

Raplixa fibrin sealant, the first approved spray-dried biologic, is a hemostatic agent that helps control bleeding from small blood vessels during surgery.

The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.

Johnson & Johnson announces partnership with NYU School of Medicine to launch a compassionate care committee for individual patient requests of investigational drugs.

The US Court of Appeals granted Amgen’s request to block Novartis’ Neupogen biosimilar, Zarxio, from the US market until the court resolves litigation between the two companies.

FDA extends ANDA rule comment period to June 8, 2015 after requests for more time.

Agency teams work together to encourage manufacturers to seek approval for previously unapproved drugs.

FDA has approved another indication for Eylea, a treatment for diabetic retinopathy in patients with diabetic macular edema.

Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.