Search results for EMA

The EU regulatory network and emerging trends – a review of quality, safety and clinical development programmes

Author byline as per print journal: Marta Zuccarelli1, PharmD; Benjamin Micallef1, PharmD; Mark Cilia1, PharmD; Anthony Serracino-Inglott1,2, PharmD; John-Joseph Borg1,3, PhD Introduction/Study Objectives: The development of biosimilars is challenging due to the complexity of the active substances as well as the strict regulatory requirements to show similarity with a reference medicinal product. This review aims […]

Read more →

Biosimilars markets: US and EU compared

Abstract: Differences between the US and European regulatory processes can lead to differences in the time taken for biosimilar approval. The European Medicines Agency is in some cases quicker to approve biosimilar drugs and Europe has overall more approved biosimilars, whilst the US approved the first biosimilar in 2015. Whatever the market, there are a […]

Read more →

Biosimilar regulation and approval in Jordan

Author byline as per print journal: Rana Musa Ali Al-ali “Malkawi”, MSc; Wesal Salem Al Haqaish, BPharm; Hayel Obeidat, MD Abstract: The regulatory oversight of medicinal products in Jordan is the responsibility of the Jordan Food and Drug Administration (JFDA). In 2015, JFDA adopted biosimilar guidelines, which are similar to those used by the European […]

Read more →

USA and Europe differ in interchangeability of biosimilars

Abstract: This paper highlights differences between USA and Europe when it comes to the interchangeability of biosimilars. The lack of harmonization between USA and Europe may introduce confusion for stakeholders and biosimilars makers and could be delaying access to life-saving treatments. Submitted: 5 December 2017; Revised: 7 December 2017; Accepted: 8 December 2017; Published online […]

Read more →

Is the EU ready for non-biological complex drug products?

Author byline as per print journal: Jon SB de Vlieger, PhD; Professor Gerrit Borchard, PharmD, PhD; Vinod P Shah, PhD; Beat Flühmann, PhD; Sesha Neervannan, PhD; Professor Stefan Mühlebach, PhD Abstract: Comment on the Regulatory paper by Dr Falk Ehmann and Dr Ruben Pita: The EU is ready for non-biological complex medicinal products, published in […]

Read more →

The EU is ready for non-biological complex medicinal products

Abstract: This paper describes the existing European Union legislation and scientific guidance to adequately assess the quality, safety and efficacy, as well as the lifecycle management, of the group of non-biological complex drug (NBCD) products, including nanomedicines such as liposomes, polymeric micelles, glatiramoids and iron-carbohydrate complexes. Submitted: 15 March 2016; Revised: 1 April 2016; Accepted: […]

Read more →

Bioequivalence of narrow therapeutic index drugs and immunosuppressives

Author byline as per print journal: Christoph Baumgärtel, MD, MSc; Brian Godman, BSc, PhD Abstract: Stricter bioequivalence criteria are in place for generics where there are narrow therapeutic indexes such as generic immunosuppressives, enhancing their acceptance despite limited published studies. No serious issues have been reported to date with generic ciclosporin despite being on the market […]

Read more →

The EU regulatory approach to generics and biosimilars is essentially similar

Abstract: Notwithstanding the scientific and regulatory differences between generic and biosimilar medicines, the European Medicines Agency/Committee for Medicinal Products for Human Use has consistently applied a ‘same active substance’ approach to both. Submitted: 28 November 2014; Revised: 20 January 2015; Accepted: 27 January 2015; Published online first: 30 January 2015 It is often stated that […]

Read more →