Latest Biosimilars News

FDA’s public hearing on biosimilars draft guidancesOn 11 May 2012, FDA held a public hearing to gain input on their draft guidances relating to the development of biosimilar products and it seems that the guidances were generally well accepted.

Immunogenicity of biologicalsThis article discusses the issue of immunogenicity with respect to originator biologicals and biosimilars was raised [1].

World Biosimilars Congress 2012Strategies for navigating the regulatory, manufacturing, sales and marketing route to biosimilars market entry

Watson to Present at the Jefferies 2012 Global Healthcare ConferencePARSIPPANY, N.J., May 25, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty global pharmaceutical company, announced today that Siggi Olafsson, Watson's President of Global Generics, will provide an overview and update of the Company's business at the Jefferies 2012 Global Healthcare Conference on Monday, June 4, 2012 at 11:00AM Eastern Time at the G...

Rising Interest of Big Pharma Creates Immense Growth Potential for Contract Manufacturing Organisations, Says Frost & SullivanLONDON, May 25, 2012 /PRNewswire/ -- Increasingly, big pharma is viewing the outsourcing of pharmaceutical manufacturing as a strategic move that would enable them to focus on their core competencies such as R&D. At the same time, the patent expiry of key blockbuster drugs worth $45 billion and biologics worth $30 billion is expected to reduce the capacity utilisation rates of their manuf...

Is Merck Less Bullish on Biosimilars?Of all the Big Pharma manufacturers, none seemed more optimistic about the commercial potential of biosimilars than Merck. But over the last several months, Merck shut down its BioVentures Group and skipped an FDA public meeting on the abbreviated ap...

BIO Lauds Senate Passage of User Fee PackageBiotechnology Industry Organization (BIO) President and CEO Jim Greenwood issued the following statement in support of the U.S. Senate’s approval of the Food and Drug Administration Safety and Innovation Act (FDASIA): “BIO commends the bipartisan Senate approval of FDASIA, which includes a reauthorization of the Prescription Drug User Fee Act...

Watson Confirms Testim® Patent ChallengePARSIPPANY, N.J., May 24, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Testosterone Gel, 1%. Watson's 1% testosterone gel product is a generic version of Auxilium Pharmaceuticals, Inc.'s Testim&...

Senate passes amended PDUFA billThe U.S. Senate voted 96-1 on Thursday to pass the PDUFA reauthorization bill with several amendments, including one from Sen. Tom Coburn (R-Okla.) that would require independent assessment of the drug review and approval process. Senators voted 54-4...

New Zoning to Highlight High-Growth Sectors at China Pharma EventsAMSTERDAM, May 23, 2012 /PRNewswire/ -- Leading events organiser UBM Live today announced details of its annual schedule of China events for the global pharmaceutical market. Set to be hosted from 26th to 28th June at the SNIEC in Shanghai, CPhI China for pharmaceutical ingredients, and ICSE China for contract and outsourced services, will be co-located with BioPh China for the biopharmaceuti...

Therapure Biopharma Receives BIOTECanada Gold Leaf AwardTherapure Biopharma Inc. is pleased to announce today that it has been awarded the Gold Leaf Award for Emerging Company of the Year by BIOTECanada in the Health Biotech Category for 2012. Therapure has been recognized as an outstanding emerging health company for the potential of its unique biomanufacturing capabilities as well as its highly innovative...

PPD Names David Simmons Chairman and CEOPharmaceutical Product Development, LLC (PPD) today announced that its board of directors has named David Simmons chairman and CEO. Mr. Simmons, an experienced pharmaceutical industry executive, joins PPD from Pfizer Inc., where he served as president and general manager of the emerging markets and established products business units. Mr. Simmons begins hi...

AbD Serotec to Launch Panel of HuCAL Anti-Drug Antibodies Supporting the Development of Novel Antibody TherapeuticsMorphoSys AG / AbD Serotec to Launch Panel of HuCAL Anti-Drug Antibodies Supporting the Development of Novel Antibody Therapeutics . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement. New Product Category Targets Contract Research Organizations and Pharmaceutical CompaniesMorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX)...

Ventria Bioscience to Participate in Business Partnering Program at 2012 BIO International ConventionFORT COLLINS, Colo. – May 23, 2012 – Company representatives from Ventria Bioscience will attend the 2012 BIO International Convention June 18 – 21 at the Boston Convention & Exhibition Center (Boston, Mass.). As in past years,...

Early Bird Discounts Available on International Healthcare and Biotechnology Conferences, Save Up To $600 with Global InformationFARMINGTON, Conn., May 22, 2012 /PRNewswire-iReach/ -- Global Information Inc is pleased to announce limited available early bird discounted registration for three significant international healthcare conferences: 2nd Annual World Health Care Congress – Latin America October 29-30, 2012 - Sao Paulo, Brazil – The 2nd Annual World Health Care Congress – Latin America builds on a...

Genpact Signs Business Process Management Engagement with Dr. Reddy's LaboratoriesNEW YORK, May 22, 2012 /PRNewswire/ -- Genpact Limited (NYSE: G), a global leader in business process and technology management, today announced that it has signed an agreement with Dr. Reddy's Laboratories (NYSE: RDY) to provide comprehensive finance and accounting (F&A) services. Genpact will take over Dr. Reddy's shared services operations in Hyderabad, India which supports the company...

Senate Begins Debate on FDA User Fee Bill with Bennet ProvisionsIncludes Bennet Measures to Improve Drug Safety, Bring Breakthrough Treatments to Patients Quicker, Advance Medical Device Innovation and Avoid Critical Drug Shortages Washington, DC – The U.S. Senate today began debate on a bipartisan bill to...

For Moderate to Severe Psoriasis, Surveyed U.S. Dermatologists Would Accept a Substantial Decrease in Efficacy Compared with Enbrel in Order to Have an Oral Therapy with a Lower Rate of Serious Infection and Comparable Safety ProfileDecision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that, for the treatment of moderate to severe psoriasis, surveyed U.S. dermatologists expect an oral therapy that meets a major achievement product profile (an oral agent with the same or lower rate of serious infections as Amgen/Pfi...

Alliance header for BIOLearn how the Alliance for Safe Biologic Medicines is working to keep the biosimilars policy discussion focused on patient sa -More-

Dr. Reddy’s Announces the Launch of Over-the-Counter Lansoprazole Delayed-Release CapsulesDr. Reddy’s Laboratories (NYSE: RDY) announced today that it has launched over-the-counter (OTC) Lansoprazole delayed-release capsules in the U.S. market on May 18, 2012, following Dr. Reddy’s ANDA approval by the United States Food & Drug Administration (USFDA). Dr. Reddy’s will market the product under store brand labels in the U.S. ma...

Biosimilar Suffix Naming Idea Trips On Dispensing ProblemAmerican Pharmacists Association tells FDA during biosimilar guidance hearing that using suffixes to create unique names will be problematic. FDA may be leaning toward the unique names, saying published literature indicates adequate safety tracking i...

Post Biocon, Pfizer Pushes Forward On Biosimilar MABsBiosimilars pioneers face a steep learning curve and multiple surprises, as shown by Pfizer’s recent and expensive backtrack on its deal with India’s Biocon. But Pfizer says the setback has reaffirmed its strategy as it pushes ahead on its own wi...

Vive la similitudeWhile there always has been contention over the rules of the road for biosimilars, the battle lines have shifted. The divide now is between biosimilars manufacturers.

Europe mulls plans to streamline biosimilar trial requirementsEurope is preparing for a major change in biosimilars regulation that the generics industry says will open the door to global biosimilars development. Assuming it goes ahead, the change could mean a huge reduction in the number of clinical trials......

Watson to Present at the Sanford C. Bernstein 28th Annual Strategic Decisions ConferencePARSIPPANY, N.J., May 18, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty global pharmaceutical company, announced today that Paul Bisaro, Watson's President and Chief Executive Officer, will provide an overview and update of the Company's business at the Sanford C. Bernstein 28th Annual Strategic Decisions Conference on Wednesday, May 30, 2012 at 4:00PM Eas...

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