Biosimilars
Savings to be made by using etanercept biosimilar in UK
A study of patients taking etanercept to treat rheumatoid arthritis or psoriasis in the UK has shown that there are substantial savings to be made by using the biosimilar [1].
FDA updates Purple Book for biologicals and biosimilars
On 21 February 2017, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced the availability of an updated version of the ‘Purple Book’.
Russian approval for non-originator interferon beta-1a
Russian biotechnology company Biocad announced on 3 March 2017 that the Russian Ministry of Health had approved the company’s interferon beta-1a non-originator biological drug, BCD-033. The drug is a non-originator biological of Merck’s multiple sclerosis blockbuster Rebif (interferon beta-1a).
Positive results for infliximab biosimilar in Crohn’s disease
Results of a phase III study of Celltrion’s infliximab biosimilar (Remsima; CT-P13) ‘indicate that the safety and efficacy of CT-P13 in patients with moderate-to-severe Crohn’s disease is comparable to those treated with reference infliximab’.
EC approval for first cancer biosimilar Truxima
South Korean biotechnology company Celltrion announced on 22 February 2017 that it had received European Commission (EC) approval for the marketing authorization for its rituximab biosimilar Truxima.
Biosimilars of teriparatide
Last update: 11 December 2020
Teriparatide is a recombinant form of parathyroid hormone (PTH). Teriparatide is identical to a portion of human PTH and intermittent use activates osteoblasts more than osteoclasts, which leads to an overall increase in bone. This makes it an effective anabolic, i.e., bone growing, agent. It is therefore used for the treatment of osteoporosis in postmenopausal women and men at high risk for fracture and for glucocorticoid-induced osteoporosis in men and postmenopausal women.
Candidate trastuzumab biosimilar meets equivalence requirements
Mylan and Biocon reported that their jointly developed, candidate trastuzumab biosimilar (MYL-1401O), had met equivalence requirements. The results of the study were published in the Journal of the American Medical Association (JAMA) in January 2017 [1].
Safe for IBD patients to switch to biosimilar infliximab
A UK study has shown that inflammatory bowel disease (IBD) patients can be safely switched from originator infliximab, Johnson & Johnson’s and Merck’s Remicade, to biosimilar infliximab using a managed-switching programme [1].
FDA accepts application for Mylan/Biocon’s pegfilgrastim biosimilar
Mylan and Biocon announced on 16 February 2017 that the regulatory submission for their proposed pegfilgrastim biosimilar (MYL-1401H) had been accepted by the US Food and Drug Administration (FDA).
Biocon wins three-year contract to supply insulin in Malaysia
Biocon has been awarded a contract by the Malaysian Ministry of Health to supply recombinant human insulin formulations to the country, a deal reportedly worth US$68 million.
