The EGA has called for more awareness surrounding the uptake of biosimilars in Europe after a report has shown upcoming products could cut healthcare provider spending by a quarter.
Chief among the potential drivers for the world’s biosimilar market is establishing a market in the US, which continues to stall, according to a new report.
Reliance Life Sciences has been contracted to make the first Indian biosimilar of J&J’s Remicade (infliximab), though Epirus Biopharmaceuticals says it is looking to Fujifilm for its European supply.
Merck Serono is planning to invest between €130m ($168m) and €150m ($194m) in biosimilars in 2015, depending on the outcome of ongoing Phase I studies, the company announced Thursday.
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.
Almost all of the biosimilars currently approved have been developed using a third-party research organisation according to a survey from the Association of Clinical Research Organizations (ACRO).
A new list of biopharmaceuticals published by the US FDA provides limited information with only the entries for Neupogen, Perjecta and Granix including expiry dates.
Partnerships are a mixed bag.For every oppressed group yearning to throw off the yoke of their imperialist overlords, there is an Art Garfunkel or Daryl Hall solo album to illustrate the positive impact collaboration can have.
EMD Millipore has been contracted to supply raw materials to the Samsung Biologics plant where ingredients for BM-S’ anticancer monoclonal antibody Yervoy (ipilimumab) are made.
The American Academies of Clinical Endocrinologists, dermatologists and neurologists, as well as eight other physician groups and a number of individual physicians are calling for unique names for biosimilars to better track adverse events and ensure...
Industry groups BIO and PhRMA, as well as biotech company Genentech, are taking issue with US FDA draft guidance that is designed to help companies design and use clinical pharmacology studies to help prove that a developing biosimilar is similar to its...
The lack of a biopharmaceutical "Orange book" means biosimilar developers face greater litigation risk than their generic counterparts according to one IP lawyer, who says full knowledge of all relevant patents is a must for such firms.
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.
US demand for biosimilar preclinical services is expected to rocket on the back of the US FDA’s acceptance of Sandoz’s biosimilar filing, according to Harlan Laboratories.
With the EMA’s CHMP (Committee for Medicinal Products for Human use) recommending approval for a new insulin biosimilar early last month, some in the industry are expecting an increasingly competitive field moving forward.
As the fight over naming biosimilars continues in the US, the WHO has drafted its own system of biological qualifiers to ensure biosimilars remain unique from their biologic counterparts.
Scientists from USP (US Pharmacopoeia), Apotex and an advisory board established by Amgen are all weighing in with suggestions and points of further clarity on the latest US FDA draft guidance on biosimilars.
Amgen says it will continue to invest in manufacturing technologies to support its biosimilar pipeline despite announcing a restructuring that will reduce its manufacturing footprint by 23%.
Mailroom and legal staff at Sandoz and Amgen are in for a busy six months after the US FDA agreed to review a biosimilar version of the anti-infective, Neupogen.
UK industry groups have rejected the idea their call for doctors to use brand names rather than INNs in new biosimilars FAQ documents is about protecting member firms’ market share.
Biosimilars are not analogous to small molecule generics in terms of market share loss according to Johnson & Johnson, which is confident its biopharmaceutical portfolio can withstand competition.
With almost three decades of recombinant protein production experience, Novartis is now seeing its work paying off as its biosimilars grew by 23% over the same quarter last year to $420m (€310.5m) in Q2.
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...
The EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion and recommended granting a marketing authorisation to Boehringer Ingelheim and Eli Lilly’s biosimilar insulin treatment for Type 1 and Type 2 diabetes patients.
Biosimilars will not deliver the same cost savings as generic drugs and may not even gain a strong foothold in the biologics market until 2019, according to a new report from GlobalData.
The World Health Assembly (WHA) has called on governments and regulators to improve public access to affordable biosimilars, saying the price of medicines can be ‘catastrophic.’
US states continue to form disparate views of how to deal with biosimilars as Delaware Governor Jack Markell (D) signed into law last week a bill that would require pharmacists to notify prescribers if a biosimilar is substituted for a biologic.
Michigan is the latest state to see a biosimilars bill come before its legislature as states pre-emptively grapple with how to deal with an expected influx of biosimilars.
The FDA has finally released its biosimilar draft guidance for industry, which details how it will evaluate comparative analytical characterization of the biosimilar in relation to the reference product.
Hospira has predicted its biosimilar Retacrit will be approved by the US FDA from late 2016, making it among the first wave of biosimilars to be sold in the US.
The latest generation of “biobetters” which are engineered to be more effective than branded biologics are hitting the market before biosimilars and could make development of the latter pointless, an expert has said.
As the race to develop mAbs (monocolonal antibodies) heats up and companies vie for the elusive seven years exclusivity that comes with an orphan drug designation, the US FDA is now offering guidance on when two mAbs should be viewed as the same.
The US biosimilars market is becoming complicated even before the US FDA has issued manufacturers with clear guidance, thanks to a rapidly evolving patchwork of varying State substitution laws.
Catalent will provide Hisun Pharmaceuticals with cell lines to help it develop infliximab, adalimumab and alemtuzumab biosimilars for the Chinese market.
The High Court in London has revoked two patents referring to the dosage and composition of Roche’s monoclonal antibody drug Herceptin, paving the way for Hospira’s biosimilar product.
As Celltrion anticipates applying for US FDA approval for its Remsima biosimilar in the first half of 2014, the company this week filed suit in US District Court in Massachusetts against Janssen seeking to invalidate patents that would stop such a launch.
IFPMA will advocate for all biologics to have a qualifier added to their names at the WHO’s INN Consultation on April 8, the biologics giant Amgen has told BioPharma-Reporter.com.
Proposals in President Obama’s 2015 budget to reduce the market exclusivity period for biologics could save the US $4bn (€2.9bn) but have been labelled unproductive by industry groups.
Proteomics International has agreed to collaborate with inVentiv Health to develop biosimilars and biologics, which will begin with structural and functional characterization.
