Emergence of Biogenerics Era in Japan – It’s Time To Welcome Antibody Biosimilars of Foreign Origins Soon

With three products and eight players already in market – Japan biosimilar market will enter new phase of biosimilars with first ‘mab’ approval expected in 2014. This approval (Remicade- FY03/13A sales ¥73.5, infiximab from Nippon Kayaku by YE 14) will be marked as a milestone development because – 1.) it will open antibody biosimilar market in Japan, and 2.) the approval will be based largely from overseas data. ~ ¥200b worth of biologic products is going off patent by 2015…

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Moderate to Severe Pain: Novel Abuse Deterrent Formulation Technologies and Emergence of Novel Mechanisms in the Management of Pain

Pain is the leading cause of disability in the US, affecting more than cancer, diabetes and heart disease combined. Current analgesics for persistent pain are relatively ineffective, are associated with significant adverse effects or abuse liability, and do not reduce pain in all treated individuals. Opioids (e.g., morphine, codeine, oxycodone) are currently one of the most potent groups of analgesics used clinically, with prescriptions increasing by 50% over the past 10 years for chronic, non-cancer pain. However, there is clear…

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Hepatitis C Virus Infection

Freedom from injecting Interferon (IFN), treating major HCV genotypes WW and betting on vaccines could bring a sea of change in the treatment of HCV infection in the future. This year the first IFN-free drug options for HCV Genotype 2/3- Gilead’s Sofosbuvir/RBV (GS-7977, PDUFA Dec. 8, 2013) is expected to be approved and launched! By 2015 launch of Gilead’s Sofosbuvir/Ledipasvir (PhIII) and AbbVie/ Enanta’s (ABT-450r/ABT-472/ABT-333) should remove the need of IFN for GT1 genotype HCV patients as well! Tapping the…

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Rituximab biosimilar

Approval of Inflectra/Remsima, the first biosimilar Monoclonal antibody (Mab) from Celltrion and Hospira in EU in 2013 is a trend setter! Inflectra is a biosimilar of Johnson & Johnson's Remicade, which is approved for RA, Crohn's disease and several other conditions and had $2 billion in sales in Europe last year. This approval has further increase the optimism of companies developing and marketing biosimilars and the wait for the launch of others in queue Rituxan, Herecptin, Enbrel etc may not…

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Treating Refractory Hematological Malignancies – Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML): Emerging Therapeutics

The report provides an overview of the approved therapies for AML, MDS, unmet need and limitations of the current SOC for relapsed and refractory pts. The report highlights the competition and commercial opportunity in pursuing this therapy area – Comprehensive list of the early and late stage drugs in the clinic, their MoA and the companies developing them. Detailed financial and competitive analysis of the companies leading in the race to launch new therapies for this indication – Ambit Biosciences,…

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Risk – Reward of Developing a Herceptin Biosimilar – A Thorough Assessment

Herceptin exclusivity is expiring in major geographies and many Biosimilar players (both experienced and new entrant) are looking to have a share of this potential $6billion pie. Herceptin sales are critical to Roche as it comprises about 15% of its cumulative Pharma sales. While eying for this potentially lucrative opportunity, there are several risks and barriers that Biosimilar players should be aware. The report – “Risk-Reward of Developing a Herceptin biosimilar – A thorough assessment” looks into several aspects of…

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Hemophilia

Hemophilia is an inherited (X-linked recessive trait), lifelong bleeding disorder that prevents blood from clotting due to insufficient or lack of adequate amount of clotting factors – Factor VIII (FVIII) and Factor IX (proteins in blood that control bleeding). Plasma-derived FVIII and FIX proteins were used in the 70’s for treating these disorders but transmission of contaminating viruses reduced its use. In 1999, recombinant FVIIIs and FIX, free of viral, animal, or human proteins became the standard of care (SoC).…

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Rituxan Biosimilar

The growth in the biosimilar opportunity will be driven by several patent expiries of mega-blockbuster biologics in the next 5 years. Between 2012 and 2017, over $60b worth of sales of biologics in the US/EU will lose patent protection. Out of them, Roche’s/Biogen Idec’s Rituxan/MabThera (rituximab), Merck and JNJ’s Remicade (infliximab), and Amgen and Pfizer’s Enbrel (etanercept) had WW sales of ~$23b in 2011 and have patents expiring in EU and ROW in 2013/14. Biosimilar version of Rituxan was launched…

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Future Of GPR Agonist

Despite about half a dozen distinct targets having been innovated and introduced in the market for the oral treatment of Type 2 diabetes, ~60% of diabetics still exhibit progressive worsening of glycemic control and ~half of them end up with daily insulin. Increasing epidemiology of Type 2 diabetes due to genetic/lifestyle changes, as well as micro/macrovascular (CV) complication associated with diabetes, demands the researcher to find newer options for treating diabetes which can address other consequences along with HbA1c reduction.…

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