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General

Biosimilars of filgrastim

Last update: 23 February 2018

Filgrastim is a granulocyte colony-stimulating factor (G-CSF). Filgrastim treatment can be used to stimulate the bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy for cancer treatment.

‘Similar biologics’ approved and marketed in India

Last update: 15 February 2018

There have been established guidelines for approving generic versions of small molecule chemical drugs in India for some time already. However, no specific guidelines for ‘similar biologics’, as the Indian regulatory authorities call these products, existed in India until 2012. This has been the case despite the fact that the requirements for granting regulatory approval for such ‘similar biologics’ required more data than for a simple generic drug application [1].

Similar biotherapeutic products approved and marketed in Latin America

Last update: 15 February 2018

Regulation of similar biotherapeutic products in Latin America varies widely among different countries and many countries have yet to introduce guidance for biosimilars, Latin America is moving towards increasing standards of regulation for these products [1, 2].

Quebec adds biosimilar etanercept Erelzi to public drug plan

In August 2017, Sandoz, the generics division of Novartis, announced that its etanercept biosimilar, Erelzi, was now available in Canada [1], after the company received Health Canada approval for the biosimilar in April 2017. Quebec is now the most recent Canadian province to add Erelzi to its public drug plan for the treatment of multiple inflammatory diseases.

Glossary of key terms

Last update: 9 June 2017

Confusion may sometimes surround terms used in the fields of generics and biosimilars. This has been recognized as a problem by EMA, who has expressed the need to propose a more precise definition for biosimilars due to problems arising from imprecise usage of the terms in the scientific literature and elsewhere [1].

Mylan/Momenta announce development strategy for aflibercept biosimilar

US generics giant Mylan and partner Momenta Pharmaceuticals announced on 3 January 2017 their development strategy for their aflibercept biosimilar, M710.

Biosimilars of insulin lispro

Last update: 26 January 2018

Insulin lispro is a fast acting insulin analogue used to treat people living with Type 1 or Type 2 diabetes. Insulin lispro has one primary advantage over regular insulin for postprandial glucose control. It has a shortened delay of onset, allowing slightly more flexibility than regular insulin, which requires a longer waiting period before starting a meal after injection. Both types should be used in combination with a longer acting insulin for good glycaemic control.

Biosimilars of teriparatide

Last update: 26 January 2018

Teriparatide is a recombinant form of parathyroid hormone (PTH). Teriparatide is identical to a portion of human PTH and intermittent use activates osteoblasts more than osteoclasts, which leads to an overall increase in bone. This makes it an effective anabolic, i.e. bone growing, agent. It is therefore used for the treatment of osteoporosis in postmenopausal women and men at high risk for fracture and for glucocorticoid-induced osteoporosis in men and postmenopausal women.

Biosimilars applications under review by EMA – January 2018

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

Roche sues Pfizer over Herceptin biosimilar

Switzerland-based drug giant Roche has sued pharma giant Pfizer for patent infringement on its blockbuster breast cancer drug Herceptin (trastuzumab) in an attempt to block competition from Pfizer’s trastuzumab biosimilar.