Biosimilars/General
WHO launches insulin prequalification programme
The World Health Organization (WHO) has announced a pilot prequalification scheme to certify biosimilar versions of insulin in order to increase supply in low- and middle-income countries.
UnitedHealthcare to preferentially cover Amgen’s anticancer biosimilars
The largest insurer in the US, UnitedHealthcare, has announced it will preferentially cover Amgen’s biosimilar cancer treatments from 1 October 2019.
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.
