Developing Oncology Biosimilars: An Essential Approach for the Future

Biosimilars in inflammatory bowel disease: A review of post-marketing experience

“…Because of their lower cost, they lead to a significant cost savings for the health community, increased earlier access to biological therapy and may facilitate the efficient allocation of the always limited financial resources[5]; more patients in the world could access biological agents earlier with also the possibility to switch from costly originator versions to biosimilar alternatives[6]. Biosimilars are expected to save 11.8-33.4 billion Euros between 2007 and 2020 in the EU and 44.2 billion US dollars over the 10-year period between 2014 and 2024[7].…”

A preliminary analysis of the reduction of chemotherapy waste in the treatment of cancer with centralization of drug preparation

“…The advantage is in the 25 to 30% reduction in price of medication. 17 On the other hand, there are uncertainties regarding the real efficacy and quality assurance of the product.…”

Scientific rationale behind the development and approval of biosimilar infliximab (CT-P13) in Europe

“…Medicines that follow-on from lowmolecular weight drugs are known as generics whereas follow-on biologics are termed similar biotherapeutic products or 'biosimilars' [2,3]. A biosimilar can be defined as a biologic that is highly similar to its originator drug (or 'reference medicinal product [RMP]') with no clinically meaningful differences in purity, safety and efficacy [2,3].…”

“…A biosimilar can be defined as a biologic that is highly similar to its originator drug (or 'reference medicinal product [RMP]') with no clinically meaningful differences in purity, safety and efficacy [2,3]. Importantly, biosimilars have the potential to reduce the pressure on healthcare budgets, as well as increase access to biologic therapy, by offering a lower-cost alternative to their RMPs [3,4].…”

“…A biosimilar can be defined as a biologic that is highly similar to its originator drug (or 'reference medicinal product [RMP]') with no clinically meaningful differences in purity, safety and efficacy [2,3]. Importantly, biosimilars have the potential to reduce the pressure on healthcare budgets, as well as increase access to biologic therapy, by offering a lower-cost alternative to their RMPs [3,4]. As of February 2015, a total of 19 biosimilars are approved by the EMA within the product classes of somatropin, epoetin, filgrastim, infliximab, insulin and follitropin (see SUPPLEMENTARY TABLE 1 [supplementary material can be found online at http://www.tandfonline.com/doi/suppl/10.1586/ 1744666X.2015.1090310]).…”