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After biosimilar versions of therapeutic proteins have become reality in Europe and in the US, now it’s the turn of therapeutic antibodies to be in the line of fire. Patents of the first wave of...
Biosimilars - news, reports, views and blogs
Biosimilars or Follow-on biologics are terms used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusi...
Tumor Necrosis Factor TNF Products
Tumor Necrosis Factor (TNF) and TNF receptor antagonists and agonists used to treat TNF-mediated inflammatory diseases such as rheumatoid arthritis or to treat cancer. TNF blockers are the commerc...
The iBioLaunch™ platform is a proprietary gene expression technology that causes non-transgenic plants to rapidly produce high levels of target proteins. The plants are easily and...
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The world’s first (official) biosimilar antibody goes to… rheumatoid arthritis
Remsima is only the first officially approved biosimilar antibody for RA therapy as Reditux, a MabThera biosimilar, was launched in India in 2007, but under unapproved biosimilar development guideline...
Positioning of biosimilars: commodity versus differentiated
How to market a new biosimilar is a key question, especially when taking into consideration the costs that are associated with developing a biosimilar. Whether the biosimilar will be a bulk (commodity...
Biotech firms try to limit biosimilar substitution in US
FDA is still to approve a biosimilar and has yet to issue final guidelines outlining the regulatory requirements for approval of a biosimilar in the US.
On Heels of Remsima Launch, Celltrion Gears Up For Herceptin Biosimilar Approval In Korea
Following the start of sales of Remsima, a biosimilar of J&J’s Remicade, Celltrion is moving to begin selling its Herceptin biosimilar in Korea this year. It will be Celltron’s second biosimil...
Guest Blog: Biosimilar terminology confusion
Imprecise usage of the term biosimilar in the literature is an issue that has already been highlighted by EMA [1 ]. The term biosimilar is [...]
XBiotech to enter biosimilar business
XBiotech, a privately held biotechnology company, announced today that it is entering the biosimilar business. The Company is launching its biosimilar business with development of two of the world's l...
Never Mind FDA, States Are Crafting Biosimilar Laws
The FDA may not have approved a biosimilar yet or decided whether a biosimilar is interchangeable with a brand-name biologic, but this is not stopping some state legislatures from considering bills th...
Biosimilar monoclonal antibodies on the horizon in Europe
EMA’s Committee for Medicinal Products for Human Use adopted the final guideline on biosimilar monoclonal antibody (mAb) and it came into effect in December 2012. The agency is also currently review...
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The advent of biosimilar therapies in rheumatology-"O Brave New World"
Patents for many key biological agents will soon expire. Third-party companies are, therefore, in the process of developing their own versions, termed biosimilar agents, of these innovator products. H...
Scientific considerations for assessing biosimilar products.
The problem for assessing biosimilarity and drug interchangeability of follow-on biologics (biosimilar products) is studied. Unlike the generic products, the development of biosimilar products is much...
As the first wave of biopharmaceuticals is expiring, biosimilars or follow-on -protein products (FOPP's) have emerged. Biosimilar drugs are cheaper than the originator/comparator drug. The regulatory...
Peripheral blood haematopoietic progenitor cell mobilization has become a standard procedure prior to autologous stem cell transplantation. Biosimilar granulocyte colony-stimulating factors (GCSF) hav...
Pharmacovigilance and biosimilars: considerations, needs and challenges.
Introduction: Biosimilars are biologic medicines that are highly similar to approved biologics, notwithstanding minor differences in clinically inactive components. Since 2007, biosimilars have been a...
