The impact of The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) on the growth and technological capabilities of the Indian pharmaceutical industry and indeed the pharmaceutical industry of other emerging countries has emerged as a critical issue in the quest for affordable healthcare for poor populations. Evidence suggests that the initial response of the Indian pha...

Allergists and clinical immunologists welcome the recent revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins (“biosimilar”) that the European Medicines Agency (EMA) has published on December 18, 2014 [1]. In the past justifiable doubts on an uncritical use of biosimilars have been formulated by most scientific societies, including our Ita...

Since the establishment of a specific approval pathway for similar biological medicinal products, so-called “biosimilars,” several biosimilars have been licensed and become available in the European Union (EU). However, despite a stringent approval process, acceptance of biosimilars in the medical community continues to be low. This appears to be especially true for therapeutic indications, for...

OBJECTIVES We examined rheumatologists' motivation for prescribing biosimilars, assessed their treatment preferences in relation to prescribing behavior and explored patient attitudes to biosimilars. METHODS Data were taken from the Adelphi Real World Biosimilars Programme, a real-world, cross-sectional study undertaken with German rheumatologists and patients with rheumatoid arthritis, ankyl...

In 2010, the Biologics Price Competition and Innovation (BPCI) Act was passed under the Patient Protection and Affordable Care Act (FDA, 2010). It created an abbreviated pathway for the approval of biologic products demonstrated to be clinically similar (or biosimilar) to or interchangeable with an approved reference product. A diverse panel of experts convened at JADPRO Live at APSHO to discus...

Biosimilars of biologics used for cancer treatment and supportive care are expected to enter the U.S. market soon. Biosimilars will be highly similar to their reference products, but unlike generic drugs, not identical. Differences between a biosimilar and its reference product may arise because of the complexity of biologics, and differences in the cell lines and processes used during manufact...

2012 will certainly be memorable as an Olympic year, but it has also seen a flurry of activity in the race to market biosimilar products. Keen to participate in this event, many countries throughout the world have established legal and regulatory pathways which allow manufacture of “copies” of a patent-expired biotherapeutic product. However, these are not simple generics as in the case of smal...