News

EMA changes biosimilar rules
Enlarge image

RegulatoryEUUKMalta

EMA changes biosimilar rules

01.10.2012 - The European Medicines Association has changed its biosimilars guidelines to make it easier to develop biologic follow-on drugs in both the US and Europe.

The London-based agency said it intends to accept batches of reference medicines sourced from outside the European Economic Area (EEA) in the future. This aims to facilitate the global development of biosimilars and avoid the unnecessary repetition of clinical trials.

Under the current European legal framework, companies developing a biosimilar medicine are required to identify a reference medicine that is or has been authorised in the European Economic Area (EEA) and whose batches are sourced from within the EEA. With the new approach, first announced by Commissioner John Dalli in Malta on 15 June 2012, the Agency will begin to accept reference medicine batches sourced from outside the EEA in certain pre-clinical and clinical studies in the comparability exercise.

A draft version of the new guidance is expectedearly next year. Since biosimilars became reality, EMA has become regardedas the most biosimilar-open agency in one of the biggest pharma markets.

© eurobiotechnews.eu/pd

http://www.european-biotechnology-news.com/news/news/2012-04/ema-accepts-foreign-biosimilar-data.html

R&DUKIreland

12.02.2016 The promise of the microbiome as the basis of new treatments has caught the attention of many. Now, UK biotherapeutics maker 4D pharma plc has padded its microbiome pipeline with the acquisition of Irish Tucana Health.

CommercialisationEU

10.02.2016 In future, meds will come in packages sporting a unique barcode and an anti-tampering device. These measures are part of the EU’s new regulation to safeguard against falsified medicines.

Clinical ResearchFrancePortugalEU

05.02.2016 It is not yet clear why a man died during a first-in-man clinical trial in January. A preliminary report found several “major shortcomings” by responsible CRO Biotrial. However, all regulations were complied with.

M&ASwitzerland

04.02.2016 After having dodged multiple takeover attempts by Monsanto last year, agrobusiness giant Syngenta has now agreed to be acquired by chemical corporation ChemChina. The Swiss company also announced plans to go public within a few years.

FinancingEUUKBelgium

01.02.2016 Newly formed Medicxi Ventures, a life sciences-dedicated VC firm based in London, Geneva and Jersey, has closed a €210m investment fund to reinvest in European early-stage assets.

ResearchUKEU

01.02.2016 Altering human DNA with the efficient gene editing method CRISPR/Cas9, especially germline modifications, was long considered a taboo. Now, however, UK scientists have received official approval to tinker with embryo DNA.

M&ASwedenIceland

28.01.2016 Swedish infectious disease specialist Enzymatica has bagged Icelandic company Zymetech, who produces the patent-protected enzyme used in Enzymatica’s own common cold blocker ColdZyme.

R&DUK

27.01.2016 Three UK universities have teamed up with three pharma companies to create the Apollo Therapeutics Fund. With the tech transfer fund, the consortium aims to develop scientific research into medicines.

Clinical TrialsGermany

25.01.2016 Affimed means to put a promising drug combination to the test. With support from MSD, the German biopharma will carry out clinical trials for an immunotherapy combining treatments of both companies.

AMREU

21.01.2016 Stop squandering antibiotics and make research profitable again: at the World Economic Forum in Swiss Davos, 83 pharmaceutical companies have called for a unified approach towards the threat of antimicrobial resistance.

Quick news provided by GlobeNewswire

View more stock news

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • PAION (D)1.77 EUR63.89%
  • 4SC (D)2.95 EUR11.32%
  • BIONOR PHARMA (N)0.86 NOK8.86%

FLOP

  • STENTYS (F)2.83 EUR-26.30%
  • BIOTIE THERAPEUTICS (FI)0.14 EUR-22.22%
  • KARO BIO (S)24.60 SEK-16.04%

TOP

  • VERONA PHARMA (UK)3.40 GBP23.6%
  • IXICO (UK)35.75 GBP21.2%
  • SERODUS (N)2.71 NOK15.8%

FLOP

  • STENTYS (F)2.83 EUR-49.0%
  • BIONOR PHARMA (N)0.86 NOK-46.2%
  • MOLMED (I)0.24 EUR-35.1%

TOP

  • CHRONTECH PHARMA (S)0.34 SEK3300.0%
  • KARO BIO (S)24.60 SEK3053.8%
  • 4SC (D)2.95 EUR243.0%

FLOP

  • NEUROVIVE PHARMACEUTICAL AB (S)8.65 SEK-86.0%
  • BIOTEST (D)13.79 EUR-85.3%
  • EVOCUTIS (UK)0.08 GBP-69.2%

No liability assumed, Date: 12.02.2016