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Monthly Archives: March 2012

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Biosimilars: Current Situation & Future Prospects, Worldwide

The engine of the biosimilar sector is the same as with small molecule drugs, patent expiry. On this basis, prospects for biosimilars look good, with the vast majority of leading originator brands in the global biologics market expected to lose some degree of protection by 2019. All major countries now make provision for an abbreviated biosimilar development and regulatory pathway. Funds are flowing into the sector and many new partnership agreements signed. Everything in the biosimilar garden might look rosy, but what is the reality?

Biosimilar sales of $16+ billion were forecast in the EU and US alone for 2011.This estimate turned out to be 50-times too high. Does publication of the long-awaited guidance on the US Biologics Price Competition and Innovation Act mean a new dawn for biosimilars, or another false one?  Written with the understandable detail and objectivity you need, Biosimilars: Current Situation & Future Prospects, Worldwide provides the answers, including:

  • On the basis of several years market experience in Europe and Japan, where and with which biosimilars has most and least success been achieved, and why.
  • Complexities of biological patents.
  • The big controversies with biosimilars explained: Sourcing of reference products, similarity, naming, interchangeability, immunogenicity, traceability, indication extrapolation.
  • Where payers incentivise usage of biosimilars.
  • The importance of devices to administer biosimilars.
  • Which companies are most active in biosimilar development, what are their targets and how far have they reached.
  • Where biosimilar prospects are brightest through 2016
    • Comprehensive:  From patents/data exclusivity via development, manufacturing issues to regulatory requirements, pricing and reimbursement demands, funding provisions and beyond to the realities of the market – it’s all here
    • Global: The situation in 27 developed and developing countries – across Europe, the Americas, Asia-Pacific and the Indian subcontinent
    • Up-to-date: Includes 2011 sales data and February 2012 proposed FDA guidance
    • Fact-filled: Over 60 tables

See the Table of Contents

For more information, see DrugPatentWatch Reports

Exciting Mid-atlantic news — North Carolina has joined Mid Atlantic Bio.

I’ve always enjoyed attending the Mid-Atlantic BIO conference, at it covers a good diversity of biotechnology companies in Maryland and Virginia. There has also been representation from North Carolina in the past, so it’s nice to see that NC has formally joined the group. I look forward to seeing more North Carolina biotechnology companies at future Mid-Atlantic BIO events!

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Drug Patent Expirations in March 2012

*Drugs may be covered by multiple patents

TradenameApplicantGeneric NamePatent NumberPatent Expiration
GEODONPfizerziprasidone mesylate4,831,031Mar 2, 2012
GEODONPfizer Incziprasidone hydrochloride4,831,031Mar 2, 2012
GEODONPfizerziprasidone hydrochloride4,831,031Mar 2, 2012
ZOFRANGlaxosmithklineondansetron hydrochloride5,344,658*PEDMar 6, 2012
GENESAGensia Automedicsarbutamine hydrochloride5,395,970Mar 7, 2012
NUTROPIN DEPOTGenentechsomatropin recombinant5,912,015Mar 12, 2012
LEXAPROForest Labsescitalopram oxalateRE34712*PEDMar 14, 2012
AVANDIASb Pharmcorosiglitazone maleate5,002,953*PEDMar 17, 2012
AVANDAMETSb Pharmcometformin hydrochloride; rosiglitazone maleate5,002,953*PEDMar 17, 2012
AVANDARYLSb Pharmcoglimepiride; rosiglitazone maleate5,002,953*PEDMar 17, 2012
BONIVARocheibandronate sodium4,927,814Mar 17, 2012
ERAXISVicuronanidulafungin6,384,013Mar 19, 2012
ERAXISVicuronanidulafungin6,743,777Mar 19, 2012
VALTURNANovartisaliskiren hemifumarate; valsartan5,399,578Mar 21, 2012
GABITRILCephalontiagabine hydrochloride5,354,760Mar 24, 2012
SEROQUELAstrazenecaquetiapine fumarate4,879,288*PEDMar 26, 2012
SEROQUEL XRAstrazenecaquetiapine fumarate4,879,288*PEDMar 26, 2012
NUEDEXTAAvanir Pharmsdextromethorphan hydrobromide; quinidine sulfate5,206,248Mar 27, 2012
FLOXIN OTICDaiichiofloxacin5,401,741Mar 27, 2012
AVALIDESanofi Aventishydrochlorothiazide; irbesartan5,270,317*PEDMar 30, 2012
AVAPROSanofi Aventis Usirbesartan5,270,317*PEDMar 30, 2012

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Courtesy of DrugPatentWatch.com