Biosimilars and Biobetters

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USP responds to FDA's draft guidance on the naming of biological products.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

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

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.

US generics manufacturer Amneal acquires a former J&J plant in Ireland.

  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?

A Federal circuit appeals court ruled that a biosimilar manufacturer will have to wait 6 months after FDA approval to commercially launch its medication.