Biosimilars
LG Chem gains approval for adalimumab biosimilar in Japan
Japan-based LG Chem (formerly LG Life Sciences) announced on 23 March 2021 in a public filing that it had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for 20 mg, 40 mg and 80 mg syringe, and 40 mg pen formulations of its adalimumab biosimilar, Adalimumab BS MA (LBAL).
Rheumatoid arthritis treatments in Australia
Analysis of the treatment landscape for rheumatoid arthritis in Australia shows that AbbVie’s Humira (adalimumab) and Pfizer’s Enbrel (etanercept) together make up half of total sales.
Expanding access to trastuzumab biological treatments
The anti-human epidermal growth factor receptor 2 (HER2) monoclonal antibody trastuzumab is indicated for treatment of HER2-positive early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC). Often used in conjunction with chemotherapy, trastuzumab was originally approved as an intravenous (IV) formulation. Subcutaneous (SC) formulations were more recently approved for HER2-positive breast cancer in 2013 (Europe) [1] and 2019 (US) [2].
CADTH summarizes evidence on switching to etanercept biosimilars
The Canadian Coordinating Office for Health Technology Assessment (CCOHTA), known today as CADTH, is an independent, not-for-profit organization responsible for providing Canada’s healthcare decision-makers with objective evidence to help make informed decisions about the optimal use of drugs and medical devices in our healthcare system.
EC approval for bevacizumab biosimilar Alymsys/Oyavas
The European Commission (EC) granted marketing authorization for the bevacizumab biosimilar Alymsys/Oyavas (MB02), on 31 March 2021. The biosimilar is developed by mAbxience, a biopharmaceutical firm with offices in Spain, Argentina and Switzerland.
Relieving the economic burden on EU healthcare budgets: spotlight on IV trastuzumab and rituximab biosimilars
In an ageing society with increasing medical need, biological treatments have played a key role in reforming the management of cancer, autoimmune and certain preventable diseases. Yet, biological treatments impose a significant financial burden on the healthcare system and healthcare payers.
Biosimilars of enoxaparin sodium
Enoxaparin sodium is an anticoagulant medication (blood thinner). It is used to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) including during pregnancy and following certain types of surgery. It is also used in those with acute coronary syndrome (ACS) and heart attacks.
Characteristics associated with biosimilar use in Medicare recipients
What patient, physician and practice characteristics are associated with biosimilar usage for the biologicals filgrastim and infliximab was a question asked by researchers from the US [1].
British Columbia adds adalimumab to biosimilar switching programme
British Columbia (BC), the first province in Canada to switch patients to biosimilar drugs, has added adalimumab to its switching programme. Almost 6,000 patients will be transitioned from originator adalimumab (Humira) to one of five biosimilar versions.
Biosimilars in the treatment of psoriasis
A recent paper by Spanish dermatologists reviews the principles of biosimilarity and equivalence trials that have led to the approval of the available adalimumab biosimilars [1]. Given the current sophistication of the analytical processes, the need to include therapeutic equivalence trials for some drug classes might be eventually waived, but they are currently standard. Equivalence trials are designed to establish that the efficacy and safety of the biosimilar are similar to those of the reference biological, with a predetermined margin of equivalence that in psoriasis ranges from ±14% to ±18%. Lower margins would imply potentially unaffordable sizes of treatment groups. The primary endpoint of the study and the timing of the determination may or may not be the same as those used in the pivotal trials of the reference biological, but the number of patients included is intentionally lower; the statistical design of equivalence trials is currently the subject of active research. In many equivalence studies, biosimilars obtain response rates higher than those reported in the pivotal studies for the originator, probably because of the absence of a placebo arm, which would tend to raise researchers’ and patients’ efficacy expectations.
