Citing “insufficient” labelling for biosimilars “given their unique scientific and regulatory status,” EuropaBio is calling on the EMA (European Medicines Agency) to amend their labelling requirements.
As Celltrion announced Monday that it filed the first monoclonal antibody for approval with the US FDA, investor groups are crying foul over some of the tactics used by others in industry to discourage the uptake of biosimilars in the US.
The fight over how biosimilars should be named in the US just got more tense as a group of pharmacists, pension systems and the Generic Pharmaceutical Association are calling for a system similar to what’s used in the EU, with the same INNs (international...
European biopharmas trying to avoid “death valley” went to California this week according to industry groups, investors and officials who met in Belgium this week to discuss ways of making it easier for companies to access funding on this side of the...
As biopharma companies look to take advantage of a biosimilar market set to exceed $3.7bn by 2016, experts say the different regulations governing the follow-on biologics may be an issue as the markets become more developed.
European Provenge contractor PharmaCell BV is looking for new business after completing the acquisition of TiGenix’s biomanufacturing facility in the Netherlands.
Revising the regulations that govern gene and cell therapies - known as advanced therapy medicinal products (ATMPs) - will increase the number of marketing authorisation applications for such products and attract more Big Pharma involvement according...
Most EU member states “strongly supported” the idea that biosimilars should be closely aligned with their reference products, according to a summary of the European Commission’s pharmaceutical committee meeting released Monday.
A biomanufacturing industry group has rejected the European Commission’s view that current regulations are flexible enough to apply to biopharmaceuticals and says more need to be done.
Kadcyla has become the second antibody-drug conjugate (ADC) to be available in Europe, triggering a $5m milestone payment by Roche to technology partner Immunogen.
With in-house production and manufacturing capacity, as well as a deal with Merck Serono, India-based generics giant Dr. Reddy’s is looking to bring as many as four biosimilars to the EU market by 2019.
US acceptance of biosimilars is “not a question of if, only of when,” according to Hospira which received a European Commission (EC) OK of its Remicade copycat yesterday.
A consortium of European vaccine experts, including the Swiss CRO Preclin Biosystems, has received almost €5.5m ($7.1m) from the EU to develop a vaccine against the deadly MRSA bacteria.
Regulators and the drug industry met in Moscow last week to develop a framework for firms developing biologics and biosimilars in the Russian Federation.
SAFC will expand manufacturing capacity at its facility in Irvine, Scotland, to include large-scale production of bulk dry powder media and reagents to save EU clients’ money in shipment costs.
European drugmakers are seeking between six months and a year to prepare and print updated product information, including the black symbol for drugs that require additional monitoring as part of their approval.
Non-clinical CRO CIT will distribute Stemina’s hES-based toxicity testing platform to pharmaceutical and cosmetics developers in Europe under an agreement announced late last week.
Pharmadule AB is creating a complete modular biologics production facility, which will be 80 per cent completed in its workshop before delivery, to Lithuania-based Silcor Biotech by 2011.
Lek has opened a 430m² modified protein manufacturing facility in Slovenia to produce epoetin alfa drug substance for use in the biosimilars marketed by its parent company, Sandoz.
The European Parliament has voted in favour of incorporating the United Nations’ (UN) Globally Harmonised System (GHS) for chemical packaging into EU law.
J&J has expressed its concern over patient safety as Novartis'
subsidiary Sandoz has received the green light from the European
Commission to launch the first epoetin alfa biosimilar on the EU
market.
The European Union's (EU) member states must take their
responsibilities to implement the biotech policy proposed by the
European Commission (EC), said EuropaBio, the EU industry body.
The French Parliament has adopted legislation which prevents
biosimilar medicinal products from being classed as generics and
bans the automatic substitution of one biological medicine for
another.
The European Commission continues to be accused by European
industry of pushing 'green policies' that are stifling progress and
global competitiveness - the controversial REACH chemicals
legislation remains a sore point.
The European Union (EU) has been criticised for being more
favourable to big biotech companies, at the expense of smaller
firms, according to consultants within the industry.
Doctors and cancer researchers have pleaded with EU politicians to
support a strong REACH chemicals regulation in order to halt an
increase in cancer rates, congenital malformations and asthma.
EU environment ministers met on Monday to further debate key issues
related to the chemical substances review, which has become one of
the fiercest political battlegrounds ever in the history of EU
policy definition.
A recent study designed to assess biopharmaceutical innovation in
the member states of the Organisation for Economic Cooperation and
Development has found that, in terms of innovation and
biotechnology industry development, Belgium...
The pharmaceutical and biotechnology industries in the 'new' EU
countries are rapidly expanding, presenting considerable potential,
although parallel imports remain a challenge.
The impact on the French chemicals industry of implementing the
European Union's REACH (Registration, Evaluation and Authorisation
of Chemicals) proposals could be as high €800 million in testing
alone and lead to the loss of...
The REACH framework for chemicals will contrary to the industry's
view, actually improve conditions for innovation in Europe,
according to EU Commissioner Erkki Liikanen.
The European Federation of Biotechnology (EFB) is setting up a
trade office in Aarhus, Denmark for its activities in innovation
and functional genomics, reports Biotech Denmark on its website.
