The EU’s take on the class of medicines known as biosimilars is a slight variation of what is seen in the US, where there are two distinct types: Follow-on biologics that are biosimilar, or "expected to produce the same clinical result as the reference product," and ones that are "interchangeable," or able to be switched with their reference product. Arguments over interchangeability in the US (from whether pharmacists should be allowed to switch a biologic for its...

The European Commission (EC) on Thursday granted two marketing authorizations for Amgen’s biosimilars for Humira (adalimumab), known as Amgevita (adalimumab) and Solymbic (adalimumab). Amgevita is authorized for all of the same indications as Humira, while Solymbic, which won approval through a duplicate marketing authorization application (MAA), is authorized for all indications except polyarticular juvenile idiopathic arthritis. Duplicate MAAs: Public Health or Co-Mar...

Three EU biopharmaceutical industry groups are offering key considerations to physicians when switching from a biologic reference product to its biosimilar or from one biosimilar of a reference product to another, according to a new position paper released on Thursday. While noting a lack of regulatory requirements for individually approved biosimilars to the same reference product to be compared with each other, the trio note: “Switching between biosimilars represents ...

The European Commission on Monday unveiled a new question and answer document for those looking to better understand biosimilars. Similar to the Focus  explainer on biosimilars , the 9-page EC explainer, available in seven languages, offers a quick 10,000-foot view of the biosimilars landscape, answering questions that patients might have on what a biologic is, what a biosimilar is, how biosimilars compare to generics, what types of studies biosimilars must undergo pri...

The US Food and Drug Administration (FDA) on Tuesday released for public consultation its long-awaited draft guidance detailing the agency's expectations for demonstrating biosimilar interchangeability. The guidance, which was initially expected to be published before the end of 2015, recommends that sponsors looking to get a biosimilar approved as interchangeable with its reference product conduct one or more switching studies to show that patients can alternate between...

The US Supreme Court on Friday said that it will review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products. The decision will not only have an impact on how biosimilar developer Sandoz and biologics company Amgen move forward in their interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) but on the US biosimilar industry as a whole. T...

In a departure from the way the WHO and Europe name biologics, the US Food and Drug Administration (FDA) on Thursday finalized long-awaited guidance on how biosimilars and their biologic reference products’ names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name. The decision to finalize this guidance follows not only several tweaks (including one that has companies submit 10 suffixes to FDA for consideratio...

The European Medicines Agency (EMA) on Friday announced that it will launch a tailored scientific advice pilot project in February 2017 to support the development of new biosimilars. The tailored procedure will advise developers on the studies they should conduct, based on a review of the quality, analytical and functional data they already have available (standard  scientific advice  does not include the assessment of existing data). EMA plans to run the pilot until ...

With the timing of all future US launches of biosimilars at stake, the US Solicitor General has called on the Supreme Court to review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products. “The proper interpretation of those provisions has a significant impact on the operation of the BPCIA [ Biologics Price Competition and Innovation Act of 2009 ] and the ability of aBLA...

A host of biosimilar experts, industry representatives and US Food and Drug Administration (FDA) officials convened on Thursday to discuss the second iteration of the Biosimilar User Fee Act (BsUFA II) and iron out the specifics of how the program needs to adapt over the next five years as the number of biosimilar applications continues to increase. FDA Commissioner Robert Califf opened the public hearing with comments on how the agency is still trying to find the righ...

The US Food and Drug Administration (FDA) on Friday announced it had approved Amgen's Amjevita (adalimumab-atto), the first biosimilar version of AbbVie's best-selling biologic Humira (adalimumab). In July, FDA's Arthritis Advisory Committee voted unanimously to support the approval. Despite the approval, FDA did not clear Amgen's biosimilar for all 10 of Humira's indications. According to FDA, both drugs share the following six indications: moderately to severely a...

Although the Food and Drug Administration (FDA) has continued to say publicly that draft guidance on how an interchangeable biosimilar will be defined should come out by the end of 2016, the user fee reauthorization commitment letter released this week says the draft will publish sometime before 31 December 2017. The letter, which contains the performance goals and procedures for the Biosimilar Biological Product User Fee Act (BsUFA) reauthorization for fiscal years 2...