Specialty Pharma Journal Specialty, Precision & Technology
By Kathleen P. Wolff, MBA Specialty Pharma Journal As consumers begin to adapt to the high cost of biologic medicines and their biosimilar counterparts, there may be a shift in education, with patients – not providers – leading the way. The concept was posed at the Biosimilars 20/20 conference this summer …
Tag Archives: Biosimilars 20/20
November, 2015
September, 2015
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9 September
Biosimilars’ Success in the US: Will Physicians Rule the Road?
By Kathleen P. Wolff, MBA Specialty Pharma Journal As the high cost of new biologic medicines sends U.S. healthcare costs soaring, payers are anxiously anticipating the introduction of biosimilar medicines – biological products, approved by FDA because they are highly similar to an already FDA-approved biological product. However, there is one …
August, 2015
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21 August
TGA Approves Hospira’s mAb Biosimilar
MELBOURNE, Australia, Aug. 19, 2015 /PRNewswire/ — Hospira today announced that InflectraTM (infliximab), the first monoclonal antibody (mAb) biosimilar therapy, has been registered in Australia. This registration paves the way for the Federal Government to reduce the cost of some of the most expensive medicines on the Pharmaceutical Benefits Scheme (PBS). …
June, 2015
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12 June
Starting Up in the Biosimilars Market: Oncobiologics’ CEO, Pankaj Mohan, on the Company’s Path to Success
In the race to bring biosimilar products to the market, many industry experts predict that pharma giants will be the winners. However, some emerging biotech companies, such as Oncobiologics, have dared to enter the sector among the established players. How will they survive? At the “Biosimilars 20/20” conference in Philadelphia, …
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12 June
Leading the Way for Biosimilars: Managed Care’s Lonely Road
By Kathleen P. Wolff, MBA Specialty Pharma Journal Forging a pathway of innovation is typically easier with friends and allies. But these days, in the world of biosimilars, where stakeholders are still sizing each other up, allies are scarce. At the Biosimilars 20/20 conference in Philadelphia, the consensus among key opinion …
May, 2015
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13 May
FDA Unveils New Guidance Document for Biosimilars
On Tuesday, the US Food and Drug Administration (FDA) released a revised document providing additional insight into how the agency plans to regulate biosimilars. The newly-released guidance document that answers common questions from companies interested in developing biosimilars, biologics license application (BLA) holders and other interested parties. The document, Biosimilars: …
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11 May
Two Biocon Biosimilars Enter Late-Stage Studies
Asia’s Biocon recently announced an update on clinical progress of its programs, saying that two of its biosimilar candidates have entered late-stage studies. The company has partnered with Britain’s Mylan on these two molecules. The companies’ pegfilgrastim (PEG-G-CSF) and Adalimumab have entered global Phase III clinical trials, which will assess …
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8 May
Court Temporarily Blocks Sale of Sandoz’s Neupogen Biosimilar
Amgen has temporarily blocked Sandoz’s Zarxio, the biosimilar version of Amgen’s Neupogen. The US Court of Appeals for the Federal Circuit in Washington has granted Amgen’s request for an injunction to stop the company from selling the drug in the US until the Court resolves the appeal. Additionally, the order …
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7 May
First Nonprofit Organization Formed Dedicated to Biosimilars
A group of leading companies involved in the development of biopharmaceuticals and biosimilars have formed the first nonprofit organization dedicated to expanding patient access to biosimilars in the US. A coalition of eleven leading companies involved in developing and manufacturing biopharmaceuticals and biosimilar drugs announced the formation of the Biosimilars …
April, 2015
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29 April
Hospira Highlights the Importance of Extrapolation for Successful Development of Biosimilars Market
Hospira highlighted the importance of extrapolation in bringing biosimilars to patients at a medical conference last week. The company encouraged regulators to continue to adopt important scientific and clinical concepts of extrapolation, noting that Europe has 21 European Medicines Agency (EMA) approved biosimilars and the US Food and Drug Administration …