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...
Copycat versions of biopharmaceuticals in the US are a step closer to reality after an FDA review committee recommended a biosimilar of Amgen’s Neupogen.
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.
Industry heavyweights and Singaporean development groups have unveiled a five-year roadmap to deal with the need for more employees in the fast-growing biologics manufacturing industry on the island.
In the ongoing fight over whether US pharmacists will be allowed to prescribe biosimilars in place of their reference products, the Generic Pharmaceutical Association has agreed on “compromise legislation” with innovator manufacturers.
AstraZeneca has continued the Big Pharma trend away from small molecule blockbusters and towards a biologics-heavy pipeline, announcing the closure of its Pulmicort facility in Massachusetts.
Stem cell therapies are on the brink of breaking through into the mainstream drug market, according to a GlobalData report, despite having been hindered by a lack of R&D funding.
Pierre Fabre has spared its biopharmaceutical research team from job cuts unveiled last night, signalling that high value biologics will be a focus for its reduced pharma R&D activities.
Manufacturers developing Ebola vaccines will be immune from lawsuits following a decision by US HHS (Health and Human Services) to issue a declaration on the matter.
The first rival to AbbVie’s mega-blockbuster arthritis treatment Humira has hit the shelves in India, with Zydus Cadila claiming its launch began on Tuesday.
Biologics are the next challenge for multinationals looking to enter the lucrative Chinese market, but such drugs must offer value and genuine innovation, say the CEOs of Merck KGaA and Chi-Med.
Ranbaxy Laboratories has launched the monoclonal antibody Infimab, the first Remicade (Infliximab) biosimilar, in India -- which is the first what could be a few home-grown biosimilar launches.
Novartis’ seasonal flu vaccine Fluad has been deemed safe by the Italian Medicines Agency (AIFA) after testing the two batches connected to over a dozen deaths.
Italy has suspended the use of Fluad despite Novartis saying no causal relationship has been established between its seasonal flu vaccine and three deaths.
A Highly Specialised Technologies programme will evaluate increasingly niche and expensive biologics and gene therapies like Glybera, says NICE as it publishes guidance recommending the funding of Alexion’s Soliris.
The Tufts Center for the Study of Drug Development is out with a new study claiming that the average cost of bringing a new drug to market is around $2.6bn, though some are saying that number seems inflated.
WuXi PharmaTech has reported a 23% growth in manufacturing services and is planning to build a commercial biomanufacturing facility to meet the strong demand for biologics.
Like the US and EU, China’s SFDA is looking to ensure that approved biosimilars are proven to be similar to their reference drugs, according to an unofficial translation of the guideline by BioCentury.
The petition with the US FDA signals Amgen’s anger over Sandoz’s failure to disclose certain information from its biosimilar application, including how the biosimilar is manufactured.
Analytical and bioanalytical service provider SGS has made significant changes to its global network over the past few months to stay ahead of the competition curve.
Reference drugs in biosimilar trials now only need to be “representative” of a product cleared in the EEA not approved themselves under guidelines issued by the EMA this week.
Despite plans to lay off more than 2,000 employees, Amgen is preparing for a biosimilar onslaught and expanding its portfolio to nine biosimilar programs.
Eli Lilly’ manufacturing network will give it the edge in the glargine insulin market, the firm says having received tentative approval of its “Lantus look-alike” from the USFDA.
As single-use technology replaces traditional stainless steel technology in biomanufacturing, suppliers will own a larger portion of the supply chain, which is creating anxiety for end users such as Pfizer and Merck, experts say.
Amgen is reviewing data from chronic kidney disease (CKD) patients to assess what impact switching to a 'biosimilar' version of its blood cell booster Aranesp (Darbepoetin Alfa) has had on their disease.
An Eli Lilly small molecule plant in Puerto Rico has been earmarked for closure as the company shifts its focus towards its insulin and biologics pipeline.
