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.
China’s food and drug administration recently gave the nod to the Beijing-based Sinovac to manufacture a vaccine to possibly prevent hand, foot and mouth disease (HFMD), a common contagious viral infection among young children.
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.
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.
CSL Behring will target growing Russian demand for protein-based therapies through a new Moscow office but says for now there are no plans for a local manufacturing site.
Samsung Bioepis will base its European operations in the UK at an entity set up to hold marketing authorizations for biosimilars it has filed for EMA review.
Sanofi Pasteur says Mexican approval for Dengvaxia vindicates the ‘industrial risk’ it took when it invested €350m in a dengue fever vaccine plant in 2009.
Korean regulators have approved a second Samsung Bioepis biosimilar, this time granting the JV rights to sell a version of J&J's Remicade (infliximab).
Preclinical CRO Biopta will add stem cell programming tech to its offering, expand in Japan and nearly double its workforce under new owner, Reprocell.
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.
The $2.4bn market for “unproven” and “unethical” biologics market “preys on vulnerable patients” and harms development of legitimate large molecule drugs, says the International Society for Cellular Therapy (ISCT).
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.
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.
Eagerly awaited interchangeability guidance will be at odds with the US FDA’s recent guidance on naming biological products using a four-letter suffix according to a panel of biosimilar experts.
Want to pass an FDA inspection? Do not answer back, do not volunteer information and do not sign anything, says an ex-auditor and regulatory consultant.
M+W has been contracted to build a £55m ($84m) manufacturing site that will support cell and gene therapy developers by the UK Government project, Cell Therapy Catapult.
Biologic drugs will be given a minimum of five years of data protection under the TPP (Trans-Pacific Partnership) trade deal agreed today, upsetting industry groups which had campaigned for 12.
