Generics - Biotechnology


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European governments' austerity pricing tactics support generic drug growth


Government initiatives to cut health expenditure are likely to encourage sales of generic medications…

BiotechnologyEuropeGenericsMarkets & MarketingPoliticsPricing

Australia's PIC reports to Ministers on treatment and reimbursement of similar biologics


The Australian Pharmaceuticals Industry Council (PIC), with industry group members AusBiotech, Medicines…


Merck KGaA collaborates with Dr Reddy's on biosimilars


With the aim of capitalizing on the batch of patent expires for blockbuster biotechnology-based drugs…

BiotechnologyDr Reddy's LaboratoriesGenericsMarkets & MarketingMerck KGaAMerck SeronoOncologyResearch

News briefs: Genmab/GSK, Gilead and Mylan


Denmark's Genmab (OMX: GEN) yesterday received a milestone payment of 20 million Danish kroner ($3.4…

Anti-viralsBiotechnologycobicistatFinancialGenericsGenmabGilead SciencesGlaxoSmithKlineMylan LaboratoriesOncologyRegulationViramune

Australia's TGA launches consultation on better medicines labeling


Australia's medicine's regulator, the Therapeutic Goods Administration, has this week released a consultation…


Erythropoietin market in Japan to reach $1.54 billion by 2015


The erythropoietin market in Japan is forecast to reach $1.54 billion by 2015 by analysts at TechNavio.…

Asia-PacificBiotechnologyGenericsMarkets & MarketingNephrology and HepatologyPatents

Biosimilars can save eight EU countries up to 33 billion euros on health care by 2020


By 2020, eight countries in the European Union could save a cumulative total of between 11.8 billion…


High expectations for new US biosimilars following FDA guidance documents


In light of the upcoming FDA guidance for biosimilar approval, Novation, health care supply chain expertise…

BiotechnologyGenericsNorth AmericaPricingRegulation

Impending patent expiries of blockbuster biologics creates huge opportunity for European biosimilars makers, says F&S


The biosimilars manufacturing industry is at a nascent stage. However, the impending patent expiries…

BiotechnologyEuropeGenericsMarkets & MarketingPatents

New biologics and biosimilars approval guidelines in Mexico


In Mexico, new guidelines are now in effect for the market authorization of biologics and biosimilars,…

BiotechnologyGenericsRegulationSouth America

Crucial need for global development of biosimilars, says head of European generics group


"The need for a framework which allows global biosimilars development is now crucial," argued European…


US medicines spending rose 3.7% in 2011, held back by healthcare reforms, IMS study reveals


Total health care spending on medicines in the USA increased 3.7% to $320 billion in 2011, a year which…

BiotechnologyGenericsHealthcareMarkets & MarketingNorth AmericaPharmaceuticalPricing

Kyowa Hakko sets up biosimilars joint venture with Fujifilm


Japanese digital camera and medical equipment conglomerate Fujifilm and drugmaker Kyowa Hakko Kirin have…

Anti-Arthritics/RheumaticsAsia-PacificBiotechnologyFujifilm Kyowa Kirin BiologicsGenericsHumiraKyowa Hakko KirinMergers & AcquisitionsResearch

Roche ups bid for Illumina; M&A speculation on Amylin, Actavis


There was a plethora of merger and acquisition news coming out yesterday and this morning, first of which…

ActavisAmylinBiotechnologyBristol-Myers SquibbGenericsIlluminaMergers & AcquisitionsMylan LaboratoriesPharmaceuticalRocheWatson Pharmaceuticals

US FDA ties up another Biosimilars loose end


The US Food and Drug Administration issuance of three long-awaited and highly anticipated draft biosimilar…

BiotechnologyGenericsNorth AmericaRegulation

Likelihood of big uptake of biosimilars by 2020 questioned


The engine of the biosimilar sector is the same as with small molecule drugs, patent expiry. On this…

BiotechnologyGenericsGlobalMarkets & MarketingPatentsRegulation

Future for biosimilars hugely promising, Momenta CEO tells GPhA meeting


Craig Wheeler, chief executive of Momenta Pharmaceuticals (Nasdaq: MNTA) discussed the promise and prospects…

BiotechnologyGenericsMarkets & MarketingMomenta PharmaceuticalsResearch

Impending biologics patent expiries creates huge opportunity for European biosimilars makers


The biosimilars manufacturing industry is at a nascent stage. However, the impending patent expiries…

BiotechnologyEuropeGenericsMarkets & MarketingPatents

Fitch backs FDA planned guidelines, saying they open the door to biosimilars


Fitch Ratings believes the US Federal Drug and Administration's proposed biosimilar pathway regulations,…

BiotechnologyGenericsHospiraNorth AmericaRegulation

At last, draft guidance on biosimilars pathway from US FDA


Coming somewhat behind European Union action, the US Food and Drug Administration late yesterday issued…

BiotechnologyGenericsNorth AmericaRegulation

Overview of biologic regulations in India


Currently, all biologics in India, including innovative and copy biologics are approved as new drugs,…


Significant advances in biosimilar medicines claimed for Iran


Iran is making significant advances in medicine production, especially in the fields of biosimilar and…

BiotechnologyGenericsMarkets & MarketingRest of the World

EMA starts review of Gilenya; guidance on biosimilar interferon beta


The European Medicines Agency has begun a review of the benefits and risks of Swiss drug major Novartis’…

BiotechnologyEuropeGenericsGilenyainterferon betaNeurologicalNovartisPharmaceuticalRegulation

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