Purpose This article aims to analyse the key regulatory guidelines across the globe
concerning biosimilars. Materials and methods Review of the current literature. Results …

Purpose: The present study compares the efficacy, safety, and immunogenicity of Lupin's
biosimilar ranibizumab with that of Lucentis® in patients with neovascular age-related …

Biological drugs, also known as first generation biopharmaceuticals, are being produced for
the last 30 years and are in clinical use for a number of diseases. Recently, the expiry of …

In recent few years, there are many epic Biological products are going off patent which has
generated an abridged route for the Biosimilars products which relies on the extensive …

Glycosylation affects clinical efficacy and safety; therefore, is a critical quality attribute of
therapeutic monoclonal antibodies. Glycans are often labile and complex in patterns, giving …

Biosimilars or similar biotherapeutic products are the biological products approved by
regulatory agencies based on the demonstration of similarity in quality, safety and efficacy …

Biosimilars are biotechnologically manufactured products that enter the market as and when
the original biopharmaceutical goes off patent. As the name suggests, they are only “similar” …

ABSTRACT A biosimilar is a biological medicinal product that contains a version of the
active substance of an already authorized original biological medicinal product (reference …

Developing new biologics has led to regulations and norms aimed at guaranteeing their
safety, quality and effectiveness, in terms of marketing, prescription, use, interchangeability …

Therapeutic monoclonal antibodies (mAbs) are structurally large and complex molecules. To
be safe and efficacious, a biosimilar mAb must show high similarity to its reference product …