Biosimilar meaning

In this issue Intellectual property Competition in life sciences Pharmaceutical regulation Medical devices Research and development Advertising of medicines LexTalk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Intellectual property Unified Patent Court cuts ribbon on Milan Central Division: Law360 notes the UPC is preparing to launch its specialised life sciences division in Milan, which commentators expect to be a busy third venue within the year‑old patent framework that alone hears revocation actions. See: Unified patent court cuts ribbon on Milan Central Division. Samsung bioepis denies infringing blood treatment patent: Law360, London: Samsung Bioepis has opposed Alexion’s attempt to stop sales of a biosimilar of a rival’s patented blood treatment medicine, telling the court the product does not breach an AstraZeneca subsidiary’s protections over the drug. See: Samsung bioepis denies infringing blood treatment patent. Judgment Alert:...

In this issue: Medical devices Research and development Pharmaceuticals—regulatory framework Business transactions Data protection Post-market Commercialisation Daily and weekly news alerts New and updated content Trackers Useful information Medical devices MLex: With core provisions of the European Artificial Intelligence (AI) Act edging towards applicability, companies and legal advisers are wrestling with whether, when and in what way the EU rulebook bites on their AI models and systems. Key uncertainties include the Act’s reach during development, any extraterritorial impact, how fundamental legal terms should be read, and the breadth of the scientific research and development exemption. See: Applicability of EU’s AI rulebook raises string of thorny questions. Commission publishes AI Continent Action Plan The European Commission has unveiled the AI Continent Action Plan to position Europe as a global AI frontrunner. The programme seeks to convert Europe’s established industries and talent base into engines for AI innovation and sits within a wider push...

In this issue: EU fundamentals Competition and state aid Data protection and cybersecurity Financial services Energy Environment IP Life sciences Regulatory TMT International trade Daily and weekly news alerts New and updated content Trackers New Q&As EU fundamentals European e-Justice Strategy 2024–2028 On 16 January 2025, the European e-Justice Strategy 2024–2028 (Strategy) was printed in the Official Journal of the EU (OJEU). It sets out a framework to advance the digitalisation of justice across the EU and continues the Union’s drive to modernise judicial systems. The initiative furthers the EU’s sustained push to update court systems EU-wide and digitally. Marco Pasqua, junior editor of the European Association of Private International Law blog, examines the Strategy. See News Analysis: European e-Justice Strategy 2024–2028. Competition and state aid Antitrust—Court of Justice clarifies jurisdiction in competition damages actions under Recast Brussels Regulation The Court of Justice delivered its...

This Practice Note sets out what are termed ‘biosimilars’, meaning comparable biological medicinal products. It outlines the commercial significance of biosimilars and highlights key challenges encountered by biosimilar manufacturers and biologic originator companies. It reviews the UK and EU regulatory regimes for these medicines and covers matters relating to biosimilar marketing authorisations (MAs), pharmacovigilance monitoring, and the manufacture and market access of biosimilars, eg pricing and reimbursement considerations. It also briefly addresses the position in the US and sets out the US Food and Drug Administration (FDA) procedures for biosimilars. In addition, it examines certain patent issues connected with biosimilars, including application of the Bolar-type exemption, considerations around the ‘clearing the way’ principle, and the Unified Patent Court (UPC), together with the scope for development of its jurisprudence concerning biosimilars. What is a biosimilar? A biosimilar is a biological medicinal product that is similar to a biological medicinal product—the originator, also referred to as the reference medicinal product—which has already been granted a MA on the basis of...

Directive 2001/83/EC (the Pharmaceutical Code) introduces a period of data exclusivity starting from the first authorisation of innovative medicinal products, during which the pre-clinical and clinical trial evidence produced to support that approval cannot be relied upon by any applicant seeking a marketing authorisation (MA) for a generic medicine. During this time, such data may not be cited or cross‑referred to by others at all. Accordingly, data exclusivity provides innovative companies with assurance that the scientific material prepared for the MA of the innovative product is safeguarded and will not be used to evaluate dossiers submitted by makers of generic or biosimilar medicines until the exclusivity enjoyed by the innovative product has expired. This protection is also termed regulatory data protection (RDP). This Practice Note sets out an overview of the relevant EU rules that govern RDP for MAs covering innovative medicinal products and considers how those rules affect the timing of market entry for generic and biosimilar medicines. It further outlines how RDP is addressed in the...

C–D | E–H | I–N | O–P | Q–V. Accelerated assessment Many countries provide a regulatory route that speeds up the appraisal of certain medicinal products, helping them reach patients sooner. In the EU, this accelerated assessment significantly shortens the period for the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to examine a marketing authorisation (MA) application from 210 to 150 evaluation days overall. An application can be considered for this pathway where the CHMP judges the product to be of major relevance for public health and therapeutic innovation. See Practice Note: Marketing authorisations in the EU—regulatory procedures for approval of medicinal products—EU centralised authorisation procedure. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) provides a 150-day review for all high‑quality new MA applications to hasten equitable access to new medicines for UK patients. The MHRA assesses applications for a UK, Great Britain (England, Wales and Scotland) or Northern Ireland MA and delivers its considered view on whether to grant...