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Here are the most relevant search results for "Generics and Biosimilars Initiative" found in our extensive news archives from over 250 global news sources.
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A review of the important events for biosimilars during 2018 are presented in this article. Some of the most memorable events for biosimilars in 2018 were the rejections by the US Food and Drug Administration (FDA) of four biosimilars and the agency’s update on its naming guideline for biologicals. Other subjects of interest for biosimilars were European Medicines Agency approvals, the US biosim...
The US Food and Drug Administration (FDA) has issued draft guidance to assist applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final approval.
On 4 December 2018, South Korean drugmaker Chong Kun Dang Pharmaceutical (CKD Pharma) announced that it had received approval for its second-generation anaemia biosimilar, CKD‑11101 (darbepoetin alfa).
In the European Union (EU) and other highly regulated markets, companies need to prove the similarity of proposed biosimilars to the established reference product for gaining market authorization. European regulators recommend using a step-wise approach whose first steps consist of a demonstration of similarity at the analytical level and via non-clinical studies. In addition, as a later step, cli...
Authors of a study carried out in Canada found that there is still uncertainty regarding generics substitution of angiotensin II receptor blockers (ARBs) .
Pfizer has presented positive phase III results for its rituximab biosimilar PF‑05280586 at the American Society of Hematology Meeting (ASH) annual meeting.
South Korean biotechnology company Celltrion announced on 5 November 2018 that it had won a patent suit in Japan involving its trastuzumab biosimilar, Herzuma (CT‑P6)
India-based generics manufacturer Dr Reddy’s is set to have a busy 2019 with the recent launch of generic omeprazole delayed-release tablets for the treatment of heartburn, and the lifting of a US injunction on its anti-narcotic addiction generic Suboxone (buprenorphine and naloxone).
Medicines for Europe 15th Legal Affairs Conference 26-27 March 2019 Hotel OkuraAmsterdam, The Netherlands
Medicines for Europe 17th Biosimilar Medicines Conference; ‘Biosimilars: Shared Journey to Access’ 28‒29 March 2019 Hotel OkuraAmsterdam, The Netherlands
The increasing prices of cancer drugs is ‘impairing the capacity of healthcare systems to provide affordable, population-wide access to cancer medicines’, according to a report issued by the World Health Organization (WHO).
The US Food and Drug Administration (FDA) announced on 11 December 2018 that it had released four guidance documents and a proposed rule on the definition of a ‘biological product’.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 13 December 2018 that it had recommended granting marketing authorization for the bevacizumab biosimilar Zirabev.
A study of long-term follow-up data after switching to biosimilar infliximab appears to show identical retention rates, according to French researchers .
Japanese firms have announced the launch of agalsidase beta and trastuzumab biosimilars in Japan on 28 November 2018.
Biosimilars Canada, an association representing Canada’s biosimilar makers, announced on 22 November 2018 that it had chosen pharmaceutical service provider Innomar Strategies to be the preferred provider for the association’s Patient Support Program (PSP) platform.
Samsung BioLogics is fighting back against allegations of accounting fraud and has launched a lawsuit against the South Korean financial authority, the Financial Services Commission (FSC).
Sandoz, the generics division of Novartis, will launch Adamis Pharmaceuticals Corp’s EpiPen (epinephrine) generic Symjepi in early 2019. Symjepi received US Food and Drug Administration (FDA) approval of its 0.3 mg pre-filled single dose syringe in June 2017 , and for its lower dose version (0.15 mg) in September 2018. Epinephrine injectors are used for the emergency treatment of life-threate...
According to authors from the US, the World Health Organization (WHO) should finalize its Biological Qualifier (BQ) guidance. Distinguishable naming will allow quick and accurate tracing of the manufacturer of biologicals, should adverse events occur and improve patient safety by reducing confusion and mishaps. This will ensure that developing nations, including those in the Middle East and North ...
International initiatives to promote the use of biosimilars and improve their understanding is just one of the subjects investigated by a report published by the Canadian Agency for Drugs and Technologies in Health (CADTH) .
The Association of British Clinical Diabetologists (ABCD) has issued a position statement on the use of biosimilar insulin. The statement summarises information on the advantages and disadvantages of using biosimilar insulins and gives the association’s position on when biosimilar insulins be used .
Epoetin alfa and pegfilgrastim biosimilars have been launched in the US at a significant discount compared to their originators.
The European Medicines Agency (EMA) announced on 29 November 2018 that the Mutual Recognition Agreement between the European Union and the US had been extended to include five additional EU Member States, Belgium, Denmark, Estonia, Finland and Latvia.
On 23 October 2018, Sandoz, the generics division of Novartis, presented positive phase III data for its adalimumab and etanercept biosimilars [1, 2].
Iraq is one of many countries determined to increase its budget savings by replacing appropriate originator biologicals with off-patent biologicals. This is due to the recognition of the proven impact off-patent biologicals have on the financial burden of healthcare systems worldwide [1, 2].