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.
FDA’s Janet Woodcook has defended delays in producing biosimilar interchangeability and labelling guidances, saying the scientific framework must first be ‘bulletproof.’
A copycat version of Amgen’s Enbrel has been approved in Korea, marking the first regulatory success for Merck & Co and Samsung Bioepis' biosimilar joint venture.
The US FDA has published long-awaited guidelines on the non-proprietary naming of biological products, but biosimilar makers say adding a random four-letter suffix could needlessly complicate the prescribing system.
A leaked draft of Trans-Pacific Partnership negotiations reveals US plans to massively broaden IP for biologics and opens the door to monopolies, says MSF.
The European Commission has approved Pfizer’s acquisition of Hospira, providing the larger company first divests of its infliximab candidate and several sterile injectables.
Attaching PEG-chains to biological molecules can increase bioavailability and speed up development of protein-based therapies and biosimilars, says EMD Millipore which has inked a deal with PEGylation firm celares.
Remicade biosimilars have had no meaningful impact on AbbVie’s parallel TNF inhibitor Humira, management says, despite international Q2 sales of the mAb being down 14% year-on-year.
With Pfizer closing in on Hospira and Sandoz set to launch Zarxio in the US, it’s been a defining week for biosimilars, our BioFinance Vision feature explains.
Novartis’ Sandoz unit will begin selling a biosimilar for Amgen’s cancer treatment Neupogen on September 2, thanks to an appeals court ruling released Tuesday.
Sales of Jonson & Johnson’s Remicade have been hit by biosimilar competition but the firm remains confident it will maintain leadership in the immunology space.
A Medicare reimbursement policy proposing that biosimilars have the same pricing code as their reference products could ultimately reduce R&D investment, according to an industry group.
The fight over how to name biosimilars has taken a turn toward further clarification, with the WHO (World Health Organization) offering another, updated draft of its intended policy on "biological qualifiers" (BQ).
Contradictory requests from the US FDA on the statistical analysis of Remsima are one of many regulatory hurdles facing biosimilar developers, according to Celltrion.
Celltrion’s Remsima campaign rolled into the US this week with another presentation of data showing that the Remicade (Infliximab) biosimilar is equivalent to the reference drug.
