Medizone Home
×
service_page_2

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

Epirus to sell CHO platform and biosimilar IP to Polpharma

As part of a cost-savings restructure, Epirus is selling the assets from its $14m acquisition of Bioceros last September to its biosimilars partner Polpharma.

Last year , Epirus Biopharmaceuticals paid $14m (€12.5m) for Netherlands-based Bioceros Holding BV, adding three biosimilar candidates and a proprietary Chinese hamster ovary (CHO) platform (CHO) for the manufacture of monoclonal antibodies.

But nine months later, the firm has announced in an SEC filing it is selling the Dutch subsidiary, including the “CHOBC cell line platform, all related intellectual property rights, a fully equipped laboratory and bioreactor capabilities” to its biosimilar development partner Polpharma for $3.5m.

The firm will retain exclusive rights to develop BOW080 and BOW070 – intended copycat versions of Alexion’s Soliris (eculizumab) and Chugai/Roche’s Actemra (tocilizumab), respectively – and said:

This decision was based on cost-savings and not due to technical reasons, the firm said in a filing in May , and was accompanied with plans to reduce the workforce by 40%. Epirus also said that with these measures it still only had “sufficient cash resources to continue its operations through the second quarter of 2016.”

The beneficiary of the sale, Polpharma, has been working with Epirus since July 2015 when the two firms struck a development and commercialisation agreement for a number of biosimilar products.

Comparator Sourcing – Clinical Trials – Medizone

Medizone campaign: Opening up new dimensions in comparator sourcing for clinical trials.
Being a pioneer means having a vision. Medizone as a strategic comparator sourcing partner for clinical trials and specialist for biosimilars focusses on integrated customized solutions with the highest standard of quality and service level.

medizone_ad_WorldPharma_online

FDA approves Inflectra, a biosimilar to Remicade

The U.S. Food and Drug Administration approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA.

Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. Inflectra is approved and can be prescribed by a health care professional for the treatment of:

  • adult patients and pediatric patients (ages six years and older) with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy;
  • adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy;
  • patients with moderately to severely active rheumatoid arthritis in combination with methotrexate;
  • patients with active ankylosing spondylitis (arthritis of the spine);
  • patients with active psoriatic arthritis;
  • adult patients with chronic severe plaque psoriasis.

The FDA’s approval of Inflectra 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 Inflectra is biosimilar to Remicade. Inflectra has been approved as biosimilar, not as an interchangeable product.

Inflectra is manufactured by Celltrion, Inc, based in Yeonsu-gu, Incheon, Republic of Korea, for Hospira.

Source: Biosimilar News

EMA accepts Sandoz’s pegfilgrastim submission

Sandoz, announced that EMA has accepted their Marketing Authorization Application for its biosimilar to Amgen’s EU-licensed Neulasta (pegfilgrastim) – a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF).

Sandoz is seeking approval for the same indication as the reference product.

Pegfilgrastim is a prescription medicine used in cancer patients (except those with chronic myeloid leukemia and myelodysplastic syndromes) to help with some of the side effects of their treatment. It reduces the duration of neutropenia and the incidence of febrile neutropenia that are a result of their chemotherapy treatment. The incidence of febrile neutropenia occurring with common chemotherapy regimens is 25 to 40% of treatment-naive patients.

“Sandoz is the leading provider of daily G-CSF in Europe and the regulatory filing of our biosimilar pegfilgrastim further cements our commitment to patients undergoing cancer treatment” said Mark McCamish, M.D., Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz.  “If approved, physicians in the EU will have another high-quality Sandoz biosimilar treatment option for patients needing granulocyte colony-stimulating factors” McCamish continued.

Sandoz believes that the totality of evidence in its submission, including three pivotal clinical trials – one pharmacokinetic and pharmacodynamic study in healthy volunteers and two comparative efficacy and safety studies in breast cancer patients – is expected to satisfy the regulatory requirements for demonstrating high similarity to the reference product and therefore justifies use of biosimilar pegfilgrastim in the reference product’s indication.

Source: Sandoz Press release

Biocad announces the trastuzumab biosimilar approval in Russia

The trastuzumab biosimilar, to be marketed under the trade name HERtiCAD, is the first trastuzumab biosimilar to receive authorization from the Russian regulatory body.

The market authorization of the trastuzumab biosimilar (fully developed and produced by BIOCAD) followed the results of a randomized multicenter clinical study comparing the pharmacokinetics, immunogenicity, safety, and efficacy of BCD-022 (trastuzumab biosimilar) to the innovator Herceptin (F. Hoffmann-La Roche Ltd).

Dmitry Morozov, founder and CEO of Biocad, said, “In 2014, world sales of the original drug trastuzumab were over $6.8 billion. Russia’s government spent over 5 billion rubles (130 mln USD) for original medicine and there are still uncovered medical need of Russian patients in trastuzumab. The approval of trastuzumab biosimilar is definitely good news for patients who previously had limited access to advanced therapeutics, and in particular for those hindered by the extra high cost of antibody biopharmaceuticals.

Biocad’s trastuzumab biosimilar is produced in a new, ultra-modern Neudorf facility set in a special economic development district outside St. Petersburg. The company has already registered two other biosimilars of rituximab and bevacizumab. Rituximab was the first mAb biosimilar approved in Russia under the trade name Acellbia and by now used in more than 6 000 patients with non-Hodgkin’s lymphoma and chronic lymphoid leukemia under federal reimbursement.

First Etanercept biosimilar Benepali receives EU approval

The joint venture between Biogen and Samsung BioLogics, Samsung Bioepis, has been granted European Commission (EC) approval for Benepali, an etanercept biosimilar referencing Enbrel.

Benepali® has been granted marketing authorization in the European Union (EU) for the treatment of adults with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis. Biogen intends to make Benepali available for patients in the coming weeks.

Benepali is the first etanercept biosimilar referencing Enbrel to be approved in the EU, making it the first subcutaneous anti-TNF biosimilar available there. Anti-TNF’s are the largest component of the EU biologics market, accounting for approximately $10 billion of all biologics sold there.

The EC approval was based on a robust preclinical and clinical data package submitted to the European Medicines Agency by Samsung Bioepis. The data in the preclinical submission leveraged sophisticated molecular analytics, technical development and manufacturing expertise. Confirmatory data from well-controlled, head-to-head Phase 1 and Phase 3 clinical trials compared Benepalito its reference product Enbrel. The 52-week, double-blind, Phase 3 study randomized 596 patients with moderate to severe RA despite methotrexate therapy, across more than 70 sites in 10 countries to receive Benepali or Enbrel in a 1:1 ratio. Analysis of the primary endpoint showed that Benepali  had equivalent efficacy to Enbrel, as shown by an ACR20 response at week 24 of 78.1% in the Benepali arm versus 80.3% in the Enbrel arm. Further analysis at 52 weeks confirmed comparable efficacy as shown by an ACR20 response of 80.8% in the Benepali arm versus 81.5% in the Enbrel arm. The safety profile of Benepali was comparable to that of Enbrel throughout the study.

Source: Biosimilar News

Amgen Biosimilars: First submission for Humira biosimilar in the United States

Amgen announced the submission of a Biologics License Application (BLA) with the United States FDA for ABP 501, a biosimilar candidate to Humira (adalimumab).

Amgen believes this submission is the first adalimumab biosimilar application submitted to the FDA and represents Amgen’s first BLA submission using the 351(k) biosimilar pathway.

“The submission of Amgen’s first biosimilar application to the FDA is an exciting milestone, expanding our inflammation portfolio to provide additional therapeutic options to patients,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Patients with chronic inflammatory conditions are faced with a significant burden of disease requiring long-term treatment. Amgen’s branded biologic medicines and biosimilars are developed and manufactured according to the same high standards, and we are committed to delivering high-quality medicines to patients with serious inflammatory diseases.”

ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-alfa monoclonal antibody, which is approved in many countries for the treatment of various inflammatory diseases.

Amgen’s BLA submission includes analytical, clinical and pharmacokinetic data. Phase 3 comparative efficacy and safety studies were conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase 3 studies met their primary endpoints showing clinical equivalence to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab. Data to support the transition of adalimumab patients to ABP 501 are included in the submission.

Source: Biosimilar News

Pages:«12345»