The US FDA has updated its draft nonproprietary naming guidance allowing drugmakers to submit up to 10 suffixes for each new biologic and biosimilar product.
Roche’s subcutaneous formulation of MabThera is about reducing the treatment burden for patients and not protecting it from impending biosimilar competition, the firm says.
Shire will retain Baxalta’s biologics expertise and continue assessing its manufacturing network following the completion of its $32bn acquisition, expected next month.
Pfizer remains confident it will launch its biosimilar Inflectra in the US this year despite J&J assuring stakeholders it will defend Remicade’s IP beyond 2018.
Fully understanding a molecule’s mode-of-action (MOA) will be essential as industry begins developing the third generation of biosimilar products, according to Formycon.
Biosimilar labeling will have to include a statement describing the product’s relationship to its reference drug, according to US FDA draft guidance published yesterday.
Biosimilar acceptance among physicians has doubled to 80% since 2013, according to a survey presented at by copycat biologic distributor Celltrion Healthcare.
Celltrion’s supply chain and warehousing procedures ensure the safe storage of Remicade biosimilars as demand fluctuates across markets, the drugmaker says.
Is the debate surrounding unique international nonproprietary names (INNs) for biosimilar products a delaying tactic driven by reference biologic makers? One market analyst believes so.
It is still too early to tell how big an impact biosimilars will have in the US, according to an IP lawyer, a year after the FDA approved Sandoz’s Zarxio.
Celltrion’s CT-P13 has been declared “highly similar” in safety and efficacy to J&J’s Remicade, and could be recommended for approval by a US FDA committee today.
Approving a biosimilar for the same diseases as the originator drug based on extrapolated data rather than study results should remain a cornerstone of the review process say regulators and developers.
As competition begins to erode worldwide sales and litigation challenges Humira’s dominance, AbbVie says it will “prevail” with its new biosimilar strategy.
Sandoz says gradual uptake of its biosimilar will eat away at Amgen’s filgastrim market share which stands at 76% four months after Zarxio’s entry in the US.
While data extrapolation is acceptable in approving US biosimilars across the same indications as its reference, the practice will not be applicable for the next generation of copycat biologics, a biotech expert says.
Benepali has become the first biosimilar of Amgen’s Enbrel (etanercept) approved in Europe and marks the first regulatory success for Samsung Bioepis – a joint venture between Samsung Biologics and Biogen.
The coming year could see a spate of biosimilar approvals in the US following Sandoz’s success in 2015, according to an IP lawyer, but questions surrounding FDA’s requirements still remain.
Having a proactive approach to delivery technologies will give pharma firms a competitive edge against biosimilars and biobetters, according to device maker Bespak.
The biosimilar market is rapidly growing after experiencing several significant developments in 2015 and is expected to be worth more than $32 billion by 2025.
The US FDA has approved Basaglar, a ‘follow-on’ version of Sanofi’s long-acting insulin Lantus developed in a joint venture between Eli Lilly and Boehringer Ingelheim.
The European Generic and Biosimilar Medicines Association (EGA) and the Spanish Generic Medicines Association (AESEG) today revealed plans to remove market barriers to biosimilars and small molecule generics and create thousands of jobs.
Epirus is set to file its Remicade biosimilar in 2017 and says the $3bn market will remain a large opportunity despite growing entrants in infliximab development.
Education is vital for biosimilar success in the US market, according to an industry advocacy group which is preparing to launch a programme for patients and healthcare providers.
Charles River has reported strong Q3 sales despite weakness in Japan and plans to grab space in emerging early discovery, bio-testing and Chinese markets.
Humira's extensive estate of over 70 formulation, manufacturing and method of treatment patents will keep US competition at bay until at least 2022, says AbbVie.
Changes to biologics manufacturing will have to go beyond swapping steel vats for single-use to adapt to future industry needs, says Amgen’s drug development expert.
The biosimilars space is becoming more crowded as new players are attracted by reduced development costs and growing market confidence, according to a panel of experts.
Remsima will soon achieve total market dominance in Norway thanks to a 69% discount on J&J’s Remicade, the man behind a trial studying the impact of biosimilar switching says.
English pharmacists are not free to dispense biosimilars in place of reference biologics, the country’s National Health Service says in its latest guidance.
