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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].

Biosimilars approved in the US

Last update: 9 February 2018

In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

Biosimilars approved in Australia

Last update: 9 February 2018

In Australia, the legal framework for approving medicines was established via the Therapeutic Goods Act 1989.

Biosimilars approved in Europe

Last update: 2 February 2018

In the European Union (EU), a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency (EMA) and not nationally.

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.

Biosimilars approved in South Korea

Last update: 12 January 2018

In South Korea, the regulatory body for the approval of medicines, including biologicals and biosimilars, is the Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administration.

Biosimilars approved in Canada

Last update: 12 January 2018

In Canada, the regulatory body for the approval of biologicals is the Biologics and Genetic Therapies Directorate (BGTD) of the Health Products and Food Branch (HPFB) of Health Canada.

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