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

Tradename Applicant Generic Name Patent Number Patent Expiration
GEODON Pfizer ziprasidone mesylate 4,831,031 Mar 2, 2012
GEODON Pfizer Inc ziprasidone hydrochloride 4,831,031 Mar 2, 2012
GEODON Pfizer ziprasidone hydrochloride 4,831,031 Mar 2, 2012
ZOFRAN Glaxosmithkline ondansetron hydrochloride 5,344,658*PED Mar 6, 2012
GENESA Gensia Automedics arbutamine hydrochloride 5,395,970 Mar 7, 2012
NUTROPIN DEPOT Genentech somatropin recombinant 5,912,015 Mar 12, 2012
LEXAPRO Forest Labs escitalopram oxalate RE34712*PED Mar 14, 2012
AVANDIA Sb Pharmco rosiglitazone maleate 5,002,953*PED Mar 17, 2012
AVANDAMET Sb Pharmco metformin hydrochloride; rosiglitazone maleate 5,002,953*PED Mar 17, 2012
AVANDARYL Sb Pharmco glimepiride; rosiglitazone maleate 5,002,953*PED Mar 17, 2012
BONIVA Roche ibandronate sodium 4,927,814 Mar 17, 2012
ERAXIS Vicuron anidulafungin 6,384,013 Mar 19, 2012
ERAXIS Vicuron anidulafungin 6,743,777 Mar 19, 2012
VALTURNA Novartis aliskiren hemifumarate; valsartan 5,399,578 Mar 21, 2012
GABITRIL Cephalon tiagabine hydrochloride 5,354,760 Mar 24, 2012
SEROQUEL Astrazeneca quetiapine fumarate 4,879,288*PED Mar 26, 2012
SEROQUEL XR Astrazeneca quetiapine fumarate 4,879,288*PED Mar 26, 2012
NUEDEXTA Avanir Pharms dextromethorphan hydrobromide; quinidine sulfate 5,206,248 Mar 27, 2012
FLOXIN OTIC Daiichi ofloxacin 5,401,741 Mar 27, 2012
AVALIDE Sanofi Aventis hydrochlorothiazide; irbesartan 5,270,317*PED Mar 30, 2012
AVAPRO Sanofi Aventis Us irbesartan 5,270,317*PED Mar 30, 2012

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Courtesy of DrugPatentWatch.com