Header graphic for print
Focus on Regulation

Tag Archives: biosimilars

FDA launches Biosimilars Action Plan to spur biologics competition, finalizes labeling guidance

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

European Commission proposes SPC waiver for EU biosimilars or generics manufactured solely for export from the EU

On 28 May 2018, the European Commission has published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products[1]. 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,

European Commission invites targeted stakeholders for consultation on duplicate marketing authorisations for biological medicinal products and biosimilars

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

EMA Adopts new Chapter to its Guidelines on Good Pharmacovigilance Practices concerning Biological Medicinal Products

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.

The Market for Biosimilars Is Growing in Spite of Unanswered Questions

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.

EMA permits the use of a comparator product authorised outside the EEA in clinical studies for biosimilars

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

European Commission adopts the black symbol to be placed in the patient information leaflets for medicinal products subject to additional monitoring in the EU

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