The wind of change is blowing in rheumatology. Rheumatologists may soon be exposed to ‘biosimilars’ of the medicines they routinely use as the European Medicines Agency (EMA) has recently issued its final guideline on biosimilar monoclonal antibodies (mAbs)—a product class of utmost importance for rheumatologists—and a biosimilar infliximab is currently under evaluation for marketing authorisat...

When the patent of an innovative (brand-name) small-molecule drug expires, generic copies of the innovative drug may be marketed if their therapeutic equivalence to the innovative drug has been shown. The small-molecule drugs are considered therapeutically equivalent and can be used interchangeably if two drugs are shown to be pharmaceutically equivalent with identical active substance and bioe...

Recently, WHO, EU, Japan and Canada have published guidelines on biosimilar/follow-on biologics. While there seems to be no significant difference in the general concept in these guidelines, the data to be submitted for product approval are partially different. Differences have been noted in the requirements for comparability studies on stability, prerequisites for reference product, or for the...

OBJECTIVE CT-P13 is a biosimilar with comparable pharmacokinetics, efficacy and safety to its reference product (RP), infliximab. Studies have shown that switching from RP to CT-P13 does not reduce the effectiveness or safety of treatment. METHODS In this retrospective real-world study, patients with inflammatory diseases treated with RP were switched to CT-P13 (n = 7) or continued on RP (n =...

Sirs, In pre-approval trials of biosimilars, fewer patients are evaluated as compared with originators. For this reason, some physicians are reluctant to employ biosimilars in clinical practice and prefer originators (1). An original approach to strengthen the clinical evidence supporting biosimilars has recently been described (2-4). According to this method, a network meta-analysis is carried...

BACKGROUND The high cost of pharmaceuticals, especially biologics, has become an important issue in the battle to control healthcare costs. The Hatch-Waxman Act encourages generic competition but still provides incentives for pioneers to develop new drugs. The Biologics Price Competition and Innovation Act is intended to do the same for biologics and biosimilars. OBJECTIVE To examine informat...

Background: Biopharmaceutical medicines represent a growing share of the global pharmaceutical market, and with many of these biopharmaceutical products facing loss of exclusivity rights, also biosimilars may now enter the biopharmaceutical market. Objectives: This study aims to identify and document which investment and development strategies are adopted by industrial players in the global bio...

The patent for some biological medicines used in the treatment of Crohn's disease are close to expire. Biosimilars are biologicals sufficiently similar to a biopharmaceutical already approved by a regulatory agency.1 Several companies are developing biosimilars to tumor necrosis factor and the first biosimilar submitted to the European agency for the treatment of rheumatoid arthritis was develo...