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Samsung Bioepis first to receive EC approval for its third anti-TNF biosimilar

Samsung Bioepis Co., Ltd. last week announced the European Commission’s (EC) approval of Imraldi, a biosimilar referencing Humira (adalimumab).

Imraldi is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis and uveitis.

With the EC’s marketing authorization of Imraldi, Samsung Bioepis becomes the industry’s first to European approvals for biosimilars referencing all three anti-TNF-alfa blockbusters. Benepali (etanercept) and Flixabi (infliximab) received EC marketing authorization in January 2016 and May 2016, respectively.

The EC approval of Imraldi applies to all 28 European Union (EU) member states as well as the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. Biogen will commercialize Imraldi in the EU and EEA member states.

The EC approval of Imraldi follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in June 2017.

Source: Biopharma News

Meet us at our booth at expopharm 2017 – 13th to 16th September

We are looking forward to welcoming you at our booth at expopharm 2017 – 13th to 16th September

Medizone – Hall 5 – Booth A23

For more information visit expopharm exhibitor directory.

Medizone_expopharm

FDA rejects Coherus’ biosimilar application for Amgen’s Neulasta

Coherus BioSciences, Inc., announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for its biologics license application for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate, under the 351(k) pathway.

The CRL primarily focused on the FDA request for a reanalysis of a subset of subject samples with a revised immunogenicity assay, and requests for certain additional manufacturing related process information. The FDA did not request a clinical study to be performed in oncology patients. Additionally, the CRL does not indicate additional process qualification lots would be required or raise concerns over the GMP status of CHS-1701 bulk manufacturing and fill-finish vendors.

Coherus states that, the company will work with the FDA to address the information requests.

“While we are disappointed in the delay that this additional request has caused, we remain confident in our ability to address the FDA’s requests for the purpose of obtaining approval for CHS-1701,” said Denny Lanfear, President and CEO of Coherus BioSciences.  

Source: Coherus BioSciences press release

Sandoz gains EU approval for biosimilar version of Roche’s MabThera

Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, announced that the European Commission (EC) has approved Rixathon (biosimilar rituximab) for use in Europe.

Rixathon is approved for use in all indications of the reference medicine, MabThera.

Rixathon is approved for non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

The EC approval was based on a comprehensive development program generating analytical, preclinical, and clinical – including pharmacokinetic/pharmacodynamic (PK/PD) – data. The program demonstrated Rixathon matches its reference medicine in terms of safety, efficacy, and quality.

Source: Sandoz Press release

Cinfa Biotech announces positive top-line data from second clinical study with pegfilgrastim biosimilar candidat

Cinfa Biotech S.L., the biosimilars company of Cinfa Group, today announced positive top-line data from the second clinical trial with its lead development candidate B12019, a biosimilar version of Neulasta (pegfilgrastim) to treat chemotherapy-induced neutropenia.

The trial demonstrated comparability of B12019 and its reference product Neulasta with regards to pharmacodynamics (PD) and immunogenicity. All primary and secondary study endpoints were met.

The multiple-dose, randomised, double-blind, three-period cross-over study enrolled 96 healthy volunteers in Germany. The study design was based on scientific advice from the European Medicines Agency (EMA) and was tailored to the specific properties of pegfilgrastim. The study met its primary endpoints: area under the effect curve (AUEC0-last) for PD and anti-drug antibody rate (ADA) for immunogenicity, confirming comparability to Neulasta. Likewise, all secondary endpoints were achieved. The safety of B12019 was also comparable to Neulasta. Further data from the trial will be presented at upcoming scientific conferences.

Pegfilgrastim is indicated for the treatment of chemotherapy-induced neutropenia. The pegylated granulocyte colony-stimulating factor (G-CSF) receptor agonist is used to stimulate bone marrow to produce more neutrophils to decrease the incidence of infection in patients undergoing chemotherapy.

Source: Cinfa Biotech press release

Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe

Sandoz, announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both Sandoz’ biosimilar rituximab and biosimilar etanercept in Europe.

The products are recommended to treat the same indications as their respective reference medicines.

“We are proud to help patients in Europe with blood cancers and immunological diseases by improving their access to effective treatments through the potential approval of not just one, but two new Sandoz biosimilar medicines,” said Mark Levick, MD PhD, Global Head of Development, Biopharmaceuticals, Sandoz. “Today’s recommendations from the CHMP will not only benefit patients, but they demonstrate our leadership in biosimilars and the strength of the Sandoz and Novartis immunology and oncology portfolios”.

The CHMP recommendations were based on two comprehensive development programs in which analytical, preclinical and clinical – including pharmacokinetic/pharmacodynamic – data were generated. The programs demonstrated biosimilarity of biosimilar rituximab and etanercept to their respective reference medicines.

Sandoz has a leading biosimilar pipeline and, in addition to biosimilar rituximab and etanercept (Erelzi approved in 2016 by the FDA), plans to launch three more biosimilars of major oncology and immunology biologics across key geographies by 2020.
Source: Sandoz press release

Meet us at our booth at ARAB HEALTH 2017 – 30th Jan to 2nd Feb

We are looking forward to welcoming you at our booth at ARAB HEALTH – Stand No. Z3.E39 in the “German Hall”.

30th January to 2nd February 2017.

For more information visit ARAB HEALTH exhibitor directory.

meizone_arabhealth

 

 

 

Mylan and Biocon filed the biosimilar Herceptin application to FDA

Mylan N.V. and Biocon Ltd. last week announced submission of Mylan’s biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, to the U.S. Food and Drug Administration (FDA) through the 351(K) pathway.

This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers. Mylan and Biocon believe that this has the potential to be the first submission of a proposed biosimilar trastuzumab in the U.S.

The submitted BLA includes a comprehensive package of analytical similarity, nonclinical and clinical data. The clinical data consists of two pharmacokinetic studies and the HERITAGE confirmatory efficacy and safety trial. The results of the HERITAGE trial were presented at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting and the European Society for Medical Oncology (ESMO) Congress.

Mylan President Rajiv Malik commented: The FDA submission for biosimilar trastuzumab marks Mylan’s first FDA biosimilar submission from our broad portfolio of biosimilar products in development and our product has the opportunity to be the first biosimilar trastuzumab approved in the U.S.

Dr Arun Chandavarkar, CEO & Joint MD, Biocon, commented: FDA is an important milestone of Biocon and Mylan’s joint global biosimilars program and demonstrates our commitment to provide access to high-quality and affordable biologics to patients across the globe.

Source: Biosimilar News

FDA approves Sandoz’ Enbrel Biosimilar

The U.S. Food and Drug Administration approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998. The newly approved drug was developed by Novartis’ Sandoz Division.

Erelzi is administered by injection for the treatment of:

  • moderate to severe rheumatoid arthritis, either as a standalone therapy or in combination with methotrexate (MTX);
  • moderate to severe polyarticular juvenile idiopathic arthritis in patients ages two and older;
  • active psoriatic arthritis, including use in combination with MTX in psoriatic arthritis patients who do not respond adequately to MTX alone;
  • active ankylosing spondylitis (an arthritis that affects the spine); and
  • chronic moderate to severe plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy.

“The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product.”

The FDA’s approval of Erelzi is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Erelzi is biosimilar to Enbrel. Erelzi has been approved as a biosimilar, not as an interchangeable product.

Coherus BioSciences announces positive Phase III results for CHS-1420 (Humira biosimilar candidate) in psoriasis patients

Coherus BioSciences, Inc., reported topline results from an ongoing Phase 3 clinical study of CHS-1420, an adalimumab (Humira) biosimilar candidate.

The study met its primary endpoint demonstrating similarity between CHS-1420 and Humira with respect to percentage of subjects achieving 75% improvement in psoriasis area and severity index (PASI-75) at Week 12. The 95% confidence intervals for the difference between treatment groups fell well within the prespecified margin. Both CHS-1420 and Humira were similarly well tolerated with similar safety profiles in this study.

This was a confirmatory, randomized, double-blind, active-control, parallel-group, 3-part study in patients with active, moderate to severe, chronic plaque psoriasis. In treatment period 2, half the subjects randomized to Humira will cross-over to CHS-1420, modeling a chronic patient’s transition to a biosimilar. Comparative safety, including immunogenicity, and durability of response to CHS-1420 and Humira at week 16 and 24 are key secondary endpoints. These data will be presented at an upcoming scientific conference. The full dataset through treatment period 2 will be available in Q4 2016 and included in the BLA submission to follow.

Source: Biosimilar News

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