Manufacturing, Biosimilars and Biobetters

Amgen announces FDA will review the company’s BLA for ABP 501.

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

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

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.

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.

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

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.

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

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.

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.

Manufacturers challenge details in new policies designed to promote access to important therapies.

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.

  Sandoz announced on Sept. 3, 2015 that despite the barriers erected by competitor Amgen, Sandoz officially launched Zarxio (filgrastim-sndz), its biologic version of Amgen’s neutropenia medication Neupogen (filgrastim). To complement the drug launch, Sandoz is also launching Sandoz One Source, a patient services center providing support for and information on the medication.

Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.

The Biosimilars Forum, along with numerous House members, advocated for the use of unique J-codes for biosimilars in a recent letter to CMS.

European Union regulators said Pfizer must divest its infliximab biosimilar candidate and some sterile injectables for the merger with Hospira to be completely approved.

The investment doubles the company’s capacity to meet increasing demand for its biologics contract testing and biosimilar characterization services.

  The provisions in the Trans-Pacific Partnership (TPP) dealing with patent exclusivity periods are diametrically opposed to the main goals originally outlined in the Biologics Price Competition and Innovation Act of 2009 in the Patient Care Protection and Affordable Care Act, the Biosimilars Council wrote in an open letter to President Obama on July 27, 2015.

Will AbbVie stave off biosimilar competitors by following Teva’s model for Copaxone?

According to Sartorius Stedim Biotech, this acquisition expands its service offering for process development.

The GPhA-run organization asks regulatory agencies to keep international nonproprietary naming conventions intact for biosimilars.

The decision makes Australia the first and only nation to permit automatic substitution of biosimilars.

In a Citizen Petition to FDA, AbbVie calls the current biosimilar labeling practices “legally unsound.”