On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from biosimilars, while preserving incentives for innovators to invest in further research. On July 19, FDA also published the guidance “Labeling for Biosimilar Products,” finalizing an April
On 28 May 2018, the European Commission has published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products. This proposal is intended to modify the EU rules on Supplementary Protection Certificate (SPC) and allow EU generic and biosimilar companies to manufacture versions of medicinal products still protected by a SPC,
The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorisations from stakeholders. These include entities involved in the development, manufacture and/ or commercialisation of medicinal products for human use, in particular biological medicinal products and biosimilars, patient groups, healthcare professionals as well as insurance and procurement agencies. The objective of this
In February 2017, the European Medicines Agency (“EMA”) will launch a pilot project to provide tailored scientific advice for the development of new biosimilars, i.e. biological medicinal products that are similar to a reference biological medicinal product authorised in the EU.
The European Medicines Agency (“EMA”) has adopted a new chapter to its guidelines on good pharmacovigilance practices (“GVP”). The new chapter addresses the specific challenges of pharmacovigilance relating to biological medicinal products. The chapter entitled “Product- or population-specific considerations II: Biological medicinal products” (“the Chapter”) came into effect on 16 August 2016.
Though the biosimilar market is still young, the number of companies working on biosimilar products is growing, putting pressure on regulators to make decisions on how they get approved—and on makers of the reference products on which they are based to ensure their intellectual property and market share are protected. Discussing these issues are Phil Katz, partner and head of Hogan Lovells’ FDA Pharmaceutical and Biotechnology group in the Washington, D.C., office; and Stephen Bennett, an IP partner in the London office.
In a Federal Register notice, FDA announced its draft guidance, “Nonproprietary Naming of Biological Products,” in which the agency articulates the need “for biological products licensed under the Public Health Service Act (PHS Act) to bear a nonproprietary name that includes an FDA-designated suffix.”
The European Medicines Agency’s (“EMA”) revised overarching guideline on biosimilars (“Guideline”), which was published on 23 October 2014, will come into force on 30 April 2015. The purpose of this Guideline is to describe the concept of biosimilars and to outline the general principles to be applied when generating evidence substantiating the similar nature, in
On 22 May 2014, the European Medicines Agency (“EMA”) published a finalised version of its Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (hereafter “EMA Guideline”). The revised EMA Guideline is expected to come into force in December 2014 and will replace the current guideline which came into effect
On 7 March 2013, the European Commission adopted a black triangle as the symbol to be placed on the patient information leaflets and the Summary of Product Characteristics (“SmPC”) of medicinal products “subject to additional monitoring” in the European Union (“EU”). The history of the black triangle The requirement to include a black symbol in