Biosimilars and Biobetters

The agency is seeking industry input on product-specific recommendations to facilitate generic drug development.

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.

Samsung Bioepis receives approval from the European Commission for the Enbrel Biosimilar, Benepali.

Corporate restructurings, regulatory initiatives, and biosimilars will shape biopharma development in 2016.

On Dec. 8, 2015, Sandoz, the generic pharmaceutical’s division of Novartis, announced that the European Medicines Agency (EMA) has accepted their marketing authorization application (MAA) for a biosimilar to Enbrel (etanercept), a tumor necrosis factor alpha (TNF-alpha) inhibitor.

Amgen submitted a market authorization application to EMA for ABP 501, a biosimilar candidate to Humira.

FDA released an interim response to AbbVie’s citizen petition on the labeling of biosimilars.

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

Amgen announced the submission of a BLA with the FDA for ABP 501.

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

FDA should not release naming rules for biosimilars ahead of interchangeability guidelines, says the pharmacy benefit manager.

Pharmaceutical manufacturers should not be protected from antitrust litigation simply because FTC chooses not to pursue a lawsuit, the agency wrote in a recent amicus brief.

Even though rising production and use of generic pharmaceuticals is saving billions for the nation’s healthcare system, policy makers continue to slap the industry with policies it claims will limit product development and sales.

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.

At least 70 patents for Humira will protect the legacy product from biosimilar competitors, according to information presented during the company’s third-quarter earnings call.

In 2016, Amgen will simultaneously fight off biosimilar competitors to its legacy products and prepare to file its own follow-on products with regulators.

ProBioGen plans to develop and scale-up production of a biosimilar to the mAb cancer drug trastuzumab and will transfer the commercial manufacturing process to Indonesia’s government-owned Bio Farma.

USP responds to FDA's draft guidance on the naming of biological products.

Despite considerable investment by biotech manufacturers in developing competitive biologics for the US market, gaining FDA approval of these products has turned out to be a slow and complex process.

Product labels should include more information on extrapolation, interchangeability, and the original source of clinical trial data, according to a survey of those in charge of dispensing medications.

Data protection for biologics is reduced from 12 to five years as a result of the Trans-Pacific Partnership agreement.

ABP 215, an investigational biosimilar for Avastin, was shown to be as safe and effective as its branded counterpart in trials for the treatment of advanced non-squamous non-small cell lung cancer.

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 Biosimilars Forum argues that the assignment of a unique Healthcare Common Procedure Coding System (HCPCS) for each biosimilar product is in alignment with the intent of Congress.