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February 17, 2015
Hospira’s Inflectra (infliximab), a biosimilar for Remicade, is approved by the European Commission.
The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high United States revenues to fund biopharmaceutical R&D.
February 11, 2015
The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality.
Pfenex announced that it entered into an agreement to partner with Hospira on the development and commercialization of PF582, a biosimilar candidate to Lucentis.
February 06, 2015
Amgen announced that it met primary and secondary endpoints in its biosimilar evaluation of adalimumab for the treatment of rheumatoid arthritis, when compared to Humira.
February 02, 2015
The 2016 White House Budget proposes a change to the data exclusivity period for biologics and the authority to influence drug pricing.
Ligand-binding assays are fundamental to characterizing biosimilars.
EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.
Market forces may limit the success of CMOs.
Working with biological matrices and understanding the intended use are crucial.