Biosimilar firms seeking US approval will not have to commit to share manufacturing data with reference drug firms before reviews, after the FDA rejected Amgen’s request for such a rule.
Gene-editing technology CRISPR-Cas9 must not be used to alter human DNA until the risks have been researched and the ethical issues considered, say scientists.
Speculation GSK's meningitis B vaccine Bexsero will soon be available on the UK National Health Serivice will be welcomed by campaigners, protein supplier Sandoz and its parent company, Novartis.
A district court judge from California has denied an injunction by Amgen meant to stop the launch of the first biosimilar approved by the US FDA – Sandoz’s Zarxio (filgrastim-sndz).
North Carolina is jumping on the biosimilar substitution legislation bandwagon with a new bill unveiled this week, while Massachusetts is looking to slightly tweak its law.
More than a year since California saw its previous biosimilar substitution bill vetoed by its governor and more than two years since Illinois tried its hand, both are again looking to become the ninth and tenth states to see new substitution laws.
A robust US biosimilars market is still some way off according to analysts who say interchangability, doctors’ safety concerns and patient demands should be considered alongside the regulatory environment by firms mulling entry.
Merck & Co and NGM Biopharmaceuticals have announced their collaboration on a range of biological therapeutics, including treatments for both diabetes and obesity.
The US FDA has delayed an advisory committee review of Celltrion's Remicade (infliximab) biosimilar after asking the South Korean drugmaker for more information.
Tokyo-based CMIC Holdings Co., Innovation Network Corporation of Japan (INCJ), and JSR have agreed to acquire KBI Biopharma, a contract development and manufacturing organization with facilities in Durham and Research Triangle Park, North Carolina and...
Apotex’s Neupogen (filgrastim) copycat Grastofil could be on US pharmacy shelves as early as December, after the US Food and Drug Administration (FDA) started its review this week.
Mundipharma’s associate Napp Pharmaceuticals launched Celltrion’s Remicade biosimilar Remisma in the UK today, just 24 hours after the originator lost patent protection.
Celltrion has emphasised the savings Remsima ((inflizimab) could offer at a conference in Spain as partner Napp Pharmaceuticals prepares to extend the roll out of the Remicade biosimilar to the UK.
Hospira, recently acquired by Pfizer, announced Monday the launch of the first biosimilar monoclonal antibody (mAb), Inflectra (infliximab), in major European markets, following the patent expiry of J&J’s Remicade.
The US FDA has set a date to review its first monoclonal antibody (mAb) biosimilar: a version of J&J’s Remicade marketed by Pfizer takeover target Hospira.
Big biotech firms risk the empty pipeline pitfalls of old pharma if they protect their drugs from biosimilars rather than invest in innovation, ex-Teva CEO Jeremy Levin warns.
The EMA has defended its decision to redact three Humira clinical study reports, arguing that the information held back was ‘commercially confidential.’
Sanofi will invest in biologics and vaccine manufacturing capacity in 2015 to sustain product launches and ease constraints that impacted its Sanofi Pasteur division in the past few years.
Bankrupt cell therapy firm Dendreon has attracted more suitors according to stalking horse bidder Valeant, which upped its offer for the Provenge (sipuleucel-T) developer to $400m this week.
The anti-abortion group that blames Merck & Co for the recent US measles outbreak says it would not judge parents who have children vaccinated with MMR II for the good of society.
US government scientists told a House subcommittee on oversight and investigations on Tuesday that the six months production time necessary for flu vaccine manufacturers can create difficulties for health experts selecting the appropriate virus strains...
NICE’s highly specialised technologies programme has recommended Alexion’s monoclonal antibody (mAb) Soliris despite receiving no justification for the £340,000 ($513,000) price per patient.
Biogen Idec will make Samsung Bioepis’ Enbrel (etanercept) biosimilar at the Danish plant that supplies its originator products, Tysabri (natalizumab) and Avonex (interferon beta-1a).
Amgen has benefited from enhanced regulatory discussions surrounding biosimilars, the firm says, as it develops a pipeline of nine products alongside its own biologics.
Competition is not a problem in the pre-competitive collaboration space according to the Pistoia Alliance, a non-profit R&D innovation focused group that has signed up Amgen and Lundbeck as its latest members.
Sandoz’s recommendation was an “inevitable step” in the introduction of biosimilars to the US, and the US FDA should expect more submissions according to a consultant.
Australia’s TGA (Therapeutic Goods Administration) is shifting its stance on the way it plans to name biosimilars to keep the country more in line with the WHO’s (World Health Organization) proposed policies.
President Obama in his State of the Union address has called for the power to personally make stronger trade agreements – bringing divisive EU deal TTIP closer to adoption and angering campaigners for drugs access.
So far most biosimilars filed in the US have been ‘low risk’ according to contractor BioOutsource, which warned that developers seeking approval for copycat mAbs face higher legal and regulatory hurdles than in Europe.
India-based CMO Piramal has acquired US-based sterile injectable CDMO (contract development and manufacturing organization) Coldstream Laboratories for $30.65m.
Lonza signed a flurry of biopharma-related deals and launched a number of drug industry services in the final quarter of 2014 as its efforts to focus on pharma intensified.
In an exclusive extract from her recent book On Immunity: An Innoculation, author Eula Biss describes her exploration of the social history and cultural myths surrounding vaccines.To be in with a chance of winning a copy, enter BioPharma-Reporter.com's...
The holidays are fast upon us, so let’s put ‘business’ to one side and get into the festive mood. To keep in the spirit of things, we’ve got a ‘gift’ for you – enjoy. Happy Holidays!
Baxter has sold its pandemic flu portfolio and Vero cell technology to Nanotherapeutics in preparation for the launch of its haematology and oncology-based spinout company Baxalta.
