Biosimilars/General
Brazilian oncologists favour ‘follow-on biological products’
The Brazilian Society of Clinical Oncology (SBOC) has issued a position statement on ‘follow-on biological products’ in oncology. The statement reflects the society’s views on issues such as naming, labelling, safety and efficacy, extrapolation of indications, interchangeability, switching and substitution of ‘follow-on biological products’, as well as on the potential impact ‘follow-on biological products’ may have on the financial burden in health care [1].
Spanish gastroenterologists update biosimilar position statement
The Spanish Society of Gastroenterology (Sociedad Española de Patología Digestiva,SEPD) has updated its position statement on the use of biosimilars for inflammatory bowel disease (IBD) [1]. The changes in the society’s position reflect the increasing body of evidence supporting the safety and efficacy of biosimilars.
ASCO issues position statement on biosimilars in oncology
The American Society of Clinical Oncology (ASCO) has issued a position statement on biosimilars in oncology. The statement reflects the society’s views on issues such as naming, labelling, safety and efficacy, interchangeability, switching and substitution of biosimilars, as well as on the value of biosimilars and prescriber and patient education [1].
‘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].
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.
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 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.
EC publishes biosimilar Q&A document for patients in 23 languages
On 29 November 2017, the European Commission (EC) published a patient-focused Questions and Answers (Q&A) document on biosimilar medicines aimed at patients and the general public.
