Latest Biotechnology, Pharmaceutical and Healthcare News from Generics and Biosimilars Initiative

22:09 EDT 20th August 2018 | BioPortfolio

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Showing News Articles 1–25 of 245 from Generics and Biosimilars Initiative

Friday 20th July 2018

FDA issues final guidance on biosimilar user fees

The US Food and Drug Administration (FDA) has issued final guidance on the agency’s Biosimilar User Fee Act (BsUFA) II fee structure finalizing the changes introduced since BsUFA I.

Positive phase III results for Amgen’s infliximab biosimilar

Biotech giant Amgen announced on 27 June 2018 positive data from a phase III study of their infliximab biosimilar (ABP 710) compared to Remicade (infliximab).

Patient sociodemographics and use of generics

Researchers from the US have found that poorer patients are more likely to use generics [1].

Mylan and Lupin make deal for etanercept biosimilar

Indian generics manufacturer Lupin Pharmaceuticals (Lupin) and US-based drugmaker Mylan announced on 28 June 2018 that they had made a deal to commercialize an etanercept biosimilar.

Russian court approves first compulsory licence

A court in Moscow has made history by granting a compulsory licence to Russian drugmaker Ukrenergo to make a generic version of Celgene Corporation’s (Celgene) flagship blood cancer drug Revlimid (lenalidomide).

MSF challenges hepatitis C patent in China

Médecins Sans Frontières (MSF, Doctors Without Borders) announced on 19 June 2018 that it was challenging the ‘unmerited’ patent in China for hepatitis C medicine velpatasvir from Gilead Sciences (Gilead). The health advocacy group said that ‘affordable generic versions from China could save millions of people’s lives’.

Rituximab biosimilar submitted to EMA and Rituxan gains extra indication

Poland-based Mabion announced on 1 June 2018 that its candidate rituximab biosimilar (MabionCD20) had been accepted for regulatory review by the European Medicines Agency (EMA).

Generic cancer pain relief launched in Japan

Japan-based Daiichi Sankyo announced on 15 June 2018 that it had launched a generic version of cancer pain relief Fentos Tape (fentanyl citrate tape).

Friday 13th July 2018

Biosimilars: implications for oncologists

In 2015, the US Food and Drug Administration (FDA) approved its first biosimilar, filgrastim-sndz, a biosimilar of the granulocyte colony-stimulating factor filgrastim. Since then, FDA has approved four additional biosimilar tumour necrosis factor α inhibitors, and in May 2017, the Oncology Drug Advisory Committee voted in favour of approval of an epoetin alfa biosimilar. Three biosimilar monoclo...

Pfizer gains Japanese approval for infliximab biosimilar

Pfizer Japan announced on 2 July 2018 that it had gained Japanese approval for its infliximab biosimilar.

Analytical consideration in demonstrating similarity for biosimilars

According to the US Food and Drug Administration (FDA) guideline on ‘Scientific Considerations in Demonstrating Biosimilarity to a Reference Product’ [1], ‘FDA expects that first, a sponsor will extensively characterize the proposed product and the reference product with state‐of‐the‐art technology, because extensive characterization of both products serves as the foundation for a demo...

Generic sofosbuvir and daclatasvir bioequivalent to originators

With the aim of eliminating hepatitis C (HCV) by 2030, some originator pharmaceutical companies have granted voluntary licences to generics companies to mass produce the direct-acting antivirals (DAAs) sofosbuvir and daclatasvir at low cost. In order to achieve this, generics makers need to demonstrate bioequivalent pharmacokinetics for their DAAs, compared to the originators. Therefore, researche...

Hatch aims to promote biosimilars and generics and restrict litigation

Senator Orrin Hatch filed an amendment to the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which was advanced to the Senate by the Judiciary Committee on 14 June 2018.

Positive results for infliximab and trastuzumab biosimilars

Celltrion Healthcare (Celltrion) and Samsung Bioepis have both announced positive results for their infliximab and trastuzumab biosimilars, respectively.

US pharmacies sue J&J for stifling infliximab biosimilars

Two major US pharmacy chains, Walgreen and Kroger, have sued healthcare giant Johnson & Johnson (J&J) in the US District Court Eastern District of Pennsylvania. The pharmacies allege that J&J prevented insurers from covering biosimilars of its blockbuster immunology drug Remicade (infliximab).

FDA approves first Suboxone generics for opioid dependence

The US Food and Drug Administration (FDA) announced on 14 June 2018 that it had approved the first generics of Suboxone (buprenorphine/naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence. The generics have been developed by Indian generics maker Dr Reddy’s Laboratories (Dr Reddy’s) and US-based drugmaker Mylan.

Friday 6th July 2018

FDA withdraws biosimilar statistical guidance

The US Food and Drug Administration (FDA) announced on 21 June 2018 that it had withdrawn the draft guidance on analytical studies of biosimilars. The agency does, however, plan to issue an amended version that ‘will reflect state-of-the-art techniques in the evaluation of analytical data’ and give sponsors ‘appropriate flexibility’.

Biosimilars applications under review by EMA – June 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 ...

Biosimilarity testing using very low doses of rituximab

Rituximab is a chimeric, monoclonal antibody directed against CD20 expressed on B lymphocytes [1]. Currently approved indications for use are non-Hodgkin lymphomas, chronic lymphatic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic angiitis [2]. However, rituximab is frequently used ‘off label’ for the treatment of numerous antibody-dependent autoimmune disease...

FDA rejects botulinum toxin biosimilar from Evolus

US-based Evolus announced on 16 May 2018 that the US Food and Drug Administration (FDA) had rejected its application for approval of DWP‑450 (prabotulinumtoxinA).

Analytical similarity for biosimilars

Dr Patrick Lynch, Product Quality Reviewer at the US Food and Drug Administration (FDA), gave a presentation on demonstrating analytical similarity for biosimilars at the US Drug Information Association’s Biosimilars Conference [1].

China to extend drug patents and tackle anticompetitive behaviour

According to reports, China is planning to increase patent protection on originator drugs to 25 years, increasing it by five years from the current patent protection period of 20 years. The country is also reportedly going to crack down on corruption and unfair competition in the pharmaceutical sector.

UK investigates price increases for generics

In light of recent increases in the price of generics, the UK’s Nation Audit Office (NAO) has carried out an investigation into the causes of the increases.

Pfenex makes biosimilar deals with Alvogen and NT Pharma

US-based biotech firm Pfenex has made commercialization deals for its candidate teriparatide biosimilar (PF708) in China and in the US.

Medicines for Europe 2nd Value Added Medicines Conference 2018

Medicines for Europe 2nd Value Added Medicines Conference 2018 21 November 2018 Renaissance Hotel, BrusselsBelgium

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