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Similar biotherapeutic products approved and marketed in Latin America

Last update: 29 November 2019

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

Oncology pharmacists issue position statement on biosimilars

On 4 October 2019, the International Society of Oncology Pharmacy Practitioners (ISOPP) issued their global position on the use of biosimilars in cancer treatment and supportive care.

Biosimilars of epoetin alfa

Last update: 4 November 2019

Epoetin alfa is a human erythropoietin produced in cell culture using recombinant DNA technology. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy.

Celltrion and Juno make biosimilars deal in Australia and Herzuma launches in Iraq

South Korean biotechnology company Celltrion Healthcare (Celltrion) has entered into a partnership with Juno Pharmaceuticals (Juno) to market the trastuzumab biosimilar Herzuma and rituximab biosimilar Truxima in Australia. The company also launched Herzuma in Iraq.

FDA releases new patient guidance on biosimilars

The US Food and Drug Administration (FDA) has released new patient materials on biosimilars, which explain that biosimilars are as safe and effective as their reference biological and answer a number of commonly asked questions.

Novo Nordisk to launch biosimilar insulin in the US

Novo Nordisk has announced plans to launch biosimilar versions of its NovoLog and NovoLog Mix insulin products in the US in January 2020.

Mylan’s insulin biosimilar blocked, but wins patent battle over pegfilgrastim biosimilar

Mylan has received a second complete response letter (CRL) from the US Food and Drug Administration (FDA) over its Lantus biosimilar, while a US District Court rules in their favour over their pegfilgrastim biosimilar, Fulphila.

Canadian IBD charity updates biosimilar position statement

On 5 September 2019, Crohn’s and Colitis Canada announced that it had updated its position statement on the use of biosimilars for inflammatory bowel disease (IBD). The updated position statement was published after the organization reviewed its position on biosimilars particularly related to non-medical switching policy.

Court rules Amgen’s patents on Enbrel are valid, Sandoz to appeal

After the US District Court of New Jersey ruled in Amgen’s favour on the validity of its patents for arthritis treatment Enbrel, Sandoz says it will appeal the ruling, which prevents the launch of its biosimilar Erlezi.

Momenta drops Humira biosimilar development

Momenta Pharmaceuticals Inc announced its financial results for the second quarter of 2019 on 2 August 2019. In this, they reported that they will stop the development of their Humira (adalimumab). However, they will continue to develop other biosimilar products.

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