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EuropaBio calls for EMA action on labeling of biosimilars

18-09-2014

EuropaBio has published a statement giving the perspective of the health care biotechnology industry…

BiosimilarsBiotechnologyEuropeRegulation

Premium-price biologicals and novel therapies will drive psoriatic arthritis market growth

10-09-2014

The market for psoriatic arthritis (PsA) therapies will grow nearly 66%, increasing to $3.7 billion in…

AbbVieAmgenAnti-Arthritics/RheumaticsBiosimilarsBiotechnologyEli LillyEuropeHumiraJapanMarkets & MarketingNovartisOtezlaStelaraUSAXeljanz

Green Cross Neulapeg biosimilar approved in South Korea

28-08-2014

South Korea’s Green Cross says that the country’s Ministry of Food and Drug Safety has granted marketing…

AmgenAsia-PacificBiosimilarsBiotechnologyGreen CrossNeulapegNeulastaOncologyRegulation

China monoclonal antibody research forecast to increase

China monoclonal antibody research forecast to increase

28-08-2014

Several Chinese large-scale pharmaceutical enterprises have devoted themselves to research and development…

BiosimilarsBiotechnologyChinaHengrui MedicineMarkets & MarketingQilu PharmResearchShanghai Pharmaceuticals

Celltrion files for US FDA approval of Remsima biosimilar

Celltrion files for US FDA approval of Remsima biosimilar

13-08-2014

South Korean biopharmaceutical firm Celltrion says it has completed the filing procedure to obtain US…

BiosimilarsBiotechnologyCellTrionClinical researchInflammatory diseasesinfliximabJanssen BiotechJohnson & JohnsonPatentsRegulationRemicadeRemsimaUSA

FDA issues new biosimilars guidance on exclusivity

FDA issues new biosimilars guidance on exclusivity

11-08-2014

The US Food and Drug Administration has announced the availability of a draft guidance for industry titled…

BiosimilarsBiotechnologyFinancialRegulationUSA

Harlan aims to provide expertise for biologics and biosimilars

31-07-2014

Switzerland-based Harlan Laboratories, a privately held provider of general and specialty toxicology…

BiosimilarsBiotechnologyContract research servicesHarlanRegulationResearchSwitzerlandToxicology services

Sandoz application for biosimilar Neupogen accepted by US FDA

25-07-2014

The US Food and Drug Administration has accepted the Biologics License Application for filgrastim, which…

AmgenBiosimilarsBiotechnologyFilgrastimNeupogenNovartisOncologyRegulationSandozUSAZarzio

Strides Arcolab makes strategic investment in Oncobiologics

Strides Arcolab makes strategic investment in Oncobiologics

16-07-2014

India’s Strides Arcolab has made a series of strategic investments in Oncobiologics, a privately held…

BiosimilarsBiotechnologyFinancialIndiaMergers & AcquisitionsOncobiologicsStrides Arcolab

Brazil’s Bionovis, BNDES and Fiocruz sign an investment agreement

Brazil’s Bionovis, BNDES and Fiocruz sign an investment agreement

07-07-2014

This month, the government of Brazil’s State of Rio de Janeiro, the Brazilian Development Bank (BNDES),…

BionovisBiosimilarsBiotechnologyBrazilFinancialFiocruzProductionResearch

USA’s GPhA and numerous other groups lodge concerns on biosimilars names

USA’s GPhA and numerous other groups lodge concerns on biosimilars names

02-07-2014

A total of 32 organizations have signed a letter calling on the US Food and Drug Administration to require…

BiosimilarsBiotechnologyRegulationUSA

JHL Biotech’s new $35 million financing will fund biosimilars

JHL Biotech’s new $35 million financing will fund biosimilars

22-06-2014

Taiwan biopharma company JHL Biotech say it has closed a Series B financing round of $35 million, led…

Asia-PacificBiosimilarsBiotechnologyFinancialJHL BiotechProductionResearch

EULAR: Ph III data demonstrate comparability of Epirus' BOW015 to Remicade for RA

EULAR: Ph III data demonstrate comparability of Epirus' BOW015 to Remicade for RA

12-06-2014

USA-based privately-held Epirus Biopharmaceuticals, focused on the development and commercialization…

Anti-Arthritics/RheumaticsBiosimilarsBiotechnologyBOW015EPIRUS BiopharmaceuticalsinfliximabRemicadeResearch

Lucrative biosimilars space to erode biologics market from 2019

Lucrative biosimilars space to erode biologics market from 2019

11-06-2014

The increasing prevalence of biosimilars will have a noticeably negative impact on the biologics market…

BiosimilarsBiotechnologyGlobalMarkets & MarketingRegulation

India encouraging opportunities for biotech innovation

India encouraging opportunities for biotech innovation

27-05-2014

In a bid to encourage new and innovative ideas for research and commercialization, the Indian government's…

BiosimilarsBiotechnologyFinancialIndiaResearch

Carved up ownership of Russia’s Biocad planned by Pharmstandard and Millhouse

Carved up ownership of Russia’s Biocad planned by Pharmstandard and Millhouse

23-05-2014

Russia’s largest pharma company Pharmstandard and Millhouse, an investment company owned by Russian…

BiocadBiosimilarsBiotechnologyBusiness FinanceChief executiveDrugsMergers & AcquisitionsPharmacologyPharmstandardRoman AmbromovichRussia

Roche may lose $240 million contract in Russia to Biocad biosimilar

Roche may lose $240 million contract in Russia to Biocad biosimilar

07-05-2014

Swiss drug major Roche may lose an important $240 million contract in Russia for the supply of its anti-cancer…

AcellBiaBiocadBiosimilarsBiotechnologyMabTheraMarkets & MarketingOncologyRegulationrituximabRoche

Lupin inks strategic biosimilars joint venture agreement with Yoshindo

23-04-2014

Indian drugmaker Lupin has entered into a strategic joint venture agreement with Japanese pharma company,…

BiosimilarsBiotechnologyEnbrelInflammatory diseasesJapanLicensingLupinTakeda PharmaceuticalYoshindo

Epirus to acquire Zalicus, creating a publicly-traded biosimilars enterprise

16-04-2014

Boston-based privately-held Epirus Biopharmaceuticals, focused on the global development and commercialization…

BiosimilarsBiotechnologyEPIRUS BiopharmaceuticalsMergers & AcquisitionsZalicus

Fast growth forecast for South Korean pharma market

Fast growth forecast for South Korean pharma market

02-04-2014

South Korea's pharmaceuticals market was valued at $20 billion in 2012, growing from $14.5 billion in…

Asia-PacificBiosimilarsBiotechnologyMarkets & MarketingPricingResearch

Brazil’s Cristalia gains ANVISA approval for production of biosimilar drugs

24-03-2014

The Brazilian drugmaker Cristalia has just taken another step towards its goal of producing biosimilar…

Anti-Arthritics/RheumaticsBiosimilarsBiotechnologyBrazilCristaliaEnbrelHerceptinMetabolicsNorditropinOncologyProductionRegulationSouth America

Pan-European survey calls for a shift in policy for biosimilars

Pan-European survey calls for a shift in policy for biosimilars

19-03-2014

This week, the Alliance for Safe Biologic Medicines (ASBM) disclosed the results of a survey of 470 European…

BiosimilarsBiotechnologyEuropeHealthcareRegulation

Merck names Simon Sturge as new head of biosimilars unit

Merck names Simon Sturge as new head of biosimilars unit

20-02-2014

Germany’s Merck KGaA has appointed Simon Sturge to head the biosimilars unit, effective March 1, succeeding…

BiosimilarsBiotechnologyBoardroomManagementMerck KGaA

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