• European regulators have issued a green light for Amgen and Allergan's Mvasi, marking the first biosimilar of Roche's Avastin to be approved in the region. (pharmatimes.com)
  • Mvasi is the first product borne out of an alliance between Amgen and Allergan to bag marketing authorisation from the European Commission, "highlighting the success of our joint commitment to developing cancer biosimilars," noted David Nicholson, chief research and development officer at Allergan. (pharmatimes.com)
  • Pharmaceutical companies presenting included Amgen, Inc. (fiercebiotech.com)
  • Amgen, Mylan and Samsung Bioepis' biosimilar versions are expected to be launched in the United States in January, June and July 2023, respectively while in the EU, Amgen and Biogen's biosimilars are expected to be launched this month. (zacks.com)
  • THOUSAND OAKS, Calif. and PARSIPPANY, N.J. , Dec. 19, 2011 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Watson Pharmaceuticals, Inc. (NYSE:WPI) announced today that they will collaborate to develop and commercialize, on a worldwide basis, several oncology antibody biosimilar medicines. (amgen.com)
  • The collaboration will not pursue biosimilars of Amgen 's proprietary products. (amgen.com)
  • Biosimilars provide an exciting long-term growth opportunity for Amgen. (amgen.com)
  • Several companies such as Amgen, Boehringer Ingelheim, and Pfizer are focusing on development of biosimilar drug of rituximab. (medindia.net)
  • Patent clocks are ticking regardless, and both patented biologics owners like Roche and Amgen, and biosimilars contenders Eli Lilly and Novartis are pins-and-needling their way to the finish line. (mmm-online.com)
  • Amgen has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Apotex, Inc. infringes two of its patents. (foley.com)
  • Although Amgen and Apotex cooperated in the biosimilar patent dance, it appears that they disagree on the notice requirements of 42 U.S.C. § 262(l)(8)(A). According to Amgen, Apotex "purport[ed]" to give notice on April 17, 2015, even though its product had (and has) not yet been approved. (foley.com)
  • The lower court decision had ruled in favor of Amgen, preventing Novartis from releasing its biosimilar until six months after the Food and Drug Administration approved it. (bioethics.net)
  • Amgen, the possible loser as a result of Friday's approval, has a biosimilars pipeline that includes lookalikes of AbbVie's Humira and Roche's Avastin. (mmm-online.com)
  • In an October 2014 business review Amgen projected that its lineup of nine biosimilar contenders could earn $3 billion in annual sales were they all to reach market. (mmm-online.com)
  • Amgen CEO Robert Bradway told investors during a Jan. 27 conference call that its 2015 earnings projections assumed Novartis's biosimilar could eat into sales of Neupogen. (mmm-online.com)
  • During the October presentation Amgen said one way to get doctors to trust biosimilars is to bring the company, not the brand, to the fore to make doctors comfortable with the firm's "deep biologics scientific skills and strong biologics manufacturing heritage. (mmm-online.com)
  • We believe that our extensive analytical and biocharacterization work has allowed us to create a high-quality biosimilar candidate of HUMIRA," said Jim Roach, M.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals. (cnbc.com)
  • They are running studies designed to convince doctors and insurers that patients can be easily switched from expensive biologics - such as the arthritis treatments Humira and Enbrel - to so-called biosimilars, which are almost identical variants. (statnews.com)
  • Last year, AbbVie filed a citizen's petition with the US Food and Drug Administration to argue that biosimilars need distinct labeling in a bid to slow approval of biosimilar versions of its best-selling Humira rheumatoid arthritis treatment. (statnews.com)
  • Biosimilar makers seek more leeway to submit data from clinical trials of similar products approved in the Europe and other industrial countries. (pharmexec.com)
  • clinical trials are performed if uncertainty remains regarding safety and efficacy of the biosimilar. (coalesceresearchgroup.com)
  • Thus, as noted by the authors, clinician appraisal of and confidence in biosimilars will initially depend less on large clinical trials than on preclinical and pharmacologic data establishing bioequivalence and on their own clinical experience. (coalesceresearchgroup.com)
  • Literature review of manufacturing processes of biosimilars, differences and similarities between biosimilars and the reference product, approval pathways for biosimilars, challenges in clinical trial study design and available data from clinical trials. (nih.gov)
  • Direct evidence of safety and benefit from clinical trials, post-marketing pharmacoviligance and unequivocal identification of the product as a biosimilar are requirements before approval. (nih.gov)
  • Dr. Janet Woodcock , head of CDER at the FDA has stated that the 'current system of clinical trials is broken,' and the FDA will not approve a biosimilar based on a comparative efficacy testing if other attributes fail to compare. (prnewswire.com)
  • Research and Markets has announced the addition of the 'Herceptin (Trastuzumab) Biosimilar Clinical Trial Insight' clinical trials to their offering. (prnewswire.co.uk)
  • Traditional products are created through chemical process due to simple and well-defined structure & having small molecules (Molecular weight ~150 Daltons) hence it is easy to produce identical API unlike biosimilar having large molecule (Molecular weight ~150,000 Daltons having complex structure and structural variation) needs larger clinical trials. (omicsonline.org)
  • Five overarching principles and eight consensus recommendations were generated, encompassing considerations regarding clinical trials, immunogenicity, extrapolation of indications, switching between bio-originators and biosimilars and among biosimilars, and cost. (bmj.com)
  • SMi Group are delighted to announce the 10th annual Biosimilars conference taking place on 25th and 26th of September 2019 in London, UK. (smi-online.co.uk)
  • There needs to be clear guidance and a robust system of accountability to drive faster adoption of biosimilar medicines at the clinical commissioning groups (CCG) and Hospital Trust level," he adds. (xtalks.com)
  • Biologic medicines, including biosimilars, are developed using living organisms instead of synthesized chemical compounds and are known to effectively treat a range of conditions including rheumatoid arthritis, metastatic breast cancer, non-Hodgkin lymphoma and anemia. (bio-medicine.org)
  • On June 27, 2013, Hospira's Inflectra (INX) was the first biosimilar monoclonal antibody to receive positive opinion from European Medicines Agency's Committee for Medicinal Products for Human Use for rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis. (nih.gov)
  • In semi- and unregulated markets, various copies of biologics were sold for many years before the establishment of biosimilar guidelines by the European Medicines Agency (EMA). (bccresearch.com)
  • Preface: Christian K. Schneider is Chairman, CHMP of the Similar Biological (Biosimilar) Medicinal Products Working Party (BMWP), member of the European Medicines Agency( London, United Kingdom) and works at the Paul-Ehrlich-Institut, Federal Agency for Sera and Vaccines (Langen, Germany) and at the Centre for Experimental and Clinical Infection Research (Hannover, Germany). (ebooks.com)
  • The expiration of patent protection for many biological medicines has led to the development of biosimilars in many countries around the world. (drugpatentwatch.com)
  • Among the steps Roche took to undercut Biocad was to deliberately drop prices for three cancer medicines - Avastin, Herceptin, and Rituxan/MabThera - in Russia, where the company said it sells biosimilar versions, according to a lawsuit filed earlier this month in federal court in New York. (statnews.com)
  • The strategy was to financially weaken the Russian drug maker to the point where it would be unable to remain competitive and pursue development and sales of biosimilar medicines, according to the lawsuit, which claims Roche violated US antitrust laws. (statnews.com)
  • The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for marketing authorization of Sandoz's infliximab, a proposed biosimilar to reference medicine infliximab. (pharmaceuticaldaily.com)
  • PSA believes a consensus Australian document on terminology and definitions relating to biological medicines (including biosimilar medicines) should be developed as a priority to promote accurate and common understanding of this subject. (psa.org.au)
  • By contrast, in Europe, the European Medicines Agency does not have the authority to designate biosimilars as interchangeable - this rests with the individual member states. (parexel.com)
  • Biosimilars are expected to cost 10 percent to 30 percent less than brand-name biologics and are forecast to lower the US health care bill by $44 billion over the next several years, according to a 2014 report from the RAND Corporation. (statnews.com)
  • Currently 3 biosimilar version of Herceptin are commercially available in India and Iran for the treatment of Breast cancer. (prnewswire.co.uk)
  • In an interview with ET Now , Debayan Ghosh , Founder & President, Epygen Biotech , says in five years, biosimilars is going to throw up $60 billion in India alone. (indiatimes.com)
  • India is seen as a key player in the biosimilar space with an exceptionally high number of approvals granted in the last decade compared to the global average. (reportbuyer.com)
  • A biosimilar is a copy version of an approved original biological medicine whose data protection has expired. (nih.gov)
  • A biosimilar is a biological product that is shown to be highly similar to a licensed biological product (the reference product) with no clinically meaningful differences from the reference product in terms of purity, safety, or potency. (uspharmacist.com)
  • A biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law. (europeanpharmaceuticalreview.com)
  • Generally, a biological is "twenty times more expensive per patient than traditional small-molecule pharmaceuticals. (bioethics.net)
  • However, safety issues concerning manufacturing facilities along with potential side effects of drug consumption could hamper for acceptance of infliximab biosimilar over the long run. (sbwire.com)
  • Over the past years, several biosimilars have been approved such as erythropoietin or growth factors. (nih.gov)
  • Biosimilar versions of various molecules including epoetins, insulins, somatropins, growth hormones, and follitropins have existed for several years in many markets. (parexel.com)
  • In the United States, the first biosimilar to be approved was filgrastim, a human granulocyte colony-stimulating factor. (neurosciencecme.com)
  • Recently biosimilars of granulocyte-colony-stimulating factor (G-CSF) became available for prophylaxis and treatment of postchemotherapy neutropenia and for mobilization of peripheral blood CD34+ cells for either autologous or allogeneic hematopoietic stem cell transplant. (wiley.com)
  • One is physicians' caution when switching patients who have been on a "branded" drug to a biosimilar, Goeller says. (xconomy.com)
  • Provide sufficient information and support to patients and request informed consent to switch from a biologic drug to a biosimilar insulin. (diabetes.ca)