Who can expect difficult competition in the biosimilars market?

A recent article at the Biotech Blog looks at a few of the segments they expect to see extensive competition in when it comes to the biosimilars market.

-Human growth hormones
-Recombinant insulins and modified recombinant insulins
-Follow-on versions of epoetin alfa
-Leukine®
-Drugs to combat neutropenia
-Interferon-alfa based treatments
-Rheumatoid arthritis treatments

Under current legislature, biologics automatically have 12 years of exclusivity, but after that, biosimilars can be introduced to the market. Do you agree that the areas above face the most competition? If not, what areas do you expect to see face competition?

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Biosimilars White Paper: Panacea or Poison Pill? Making Sense of the New Biosimilars Law

I recently came across the BNA, Inc. white paper "Panacea or Poison Pill? Making Sense of the New Biosimilars Law." It takes an in-depth look at the new healthcare reform that allows the streamline development and FDA approval pathway for biosimilars.

According to the paper:

This article provides a brief overview of the history leading up to passage of the Biosimilar Act, discusses in detail both the FDA regulatory and patent litigation provisions of the act (with comparisons and contrasts to the Hatch-Waxman scheme), probes potential interpretations of key provisions, and offers practical strategic considerations both for companies seeking to pursue product approvals under the new law, and for companies whose products now may face increased competition from follow-on products.

Read the white paper here.

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Covance opens new biorepository in Indiana

Covance has opened a new long term storage biorepository in Greenfeild, Indiana. With high tech security and safety features, it will be used to hold specimens such as plasma, serum, whole blood, DNA, PBMC (peripheral blood mononuclear cell) samples and tissue.

Deborah Tanner, corporate senior vice president and president, Central Laboratory Services and Discovery & Translational Services said about the new facility:
“We believe Covance has the latest technology and capacity to meet our clients’ sample storage and testing needs for many years to come. Our experience in clinical trial specimen testing and storage enables us to manage the entire lifecycle from specimen draw to final destruction, which minimises the risk for our clients due to shipping and moving specimens.”

Read the full article here.

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Cipla buys stake in biosimilars market

According to FierceBiopharma, Indian drug company Cipla has purchased major stakes in Asian biotechs that have biosimilars in the pipeline. Their main goal is to create biosimilars of current biologics that are extremely expensive, Roche's Avastin, Herceptin and Enbrel. Read the full article here.

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Combo Product submissions to FDA increased in 2009

According to the FDA, Combination Product submissions to the FDA for approval continue to increase. According to the webpage, there were 329 submissions in 2008, which increased to 330 in 2009. Read more about the trends in combination products submissions to the FDA here.

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Pfizer receives warning unreported drug complaints

According to Forbes, the FDA has issued a warning to Pfizer for failing to report drug complaints that involved serious injuries to them within the allotted 15 day period. This is in addition to the 13% of complaints that were submitted late between March 2006 and July 2009.

Pfizer responded:

"We are committed to full compliance and timely and accurate submission of individual adverse-event reports."

Read the full article here.

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Abbott, Bayer, GlaxoSmithKline & Pfizer gather at Shopper Insights in Action

Consumer healthcare brands and over the counter medicines are a multi-billion dollar industry. Brand marketers at leading pharmaceutical companies are charged with ensuring their brand pops off the shelf and into the shopper's basket. Understanding consumer and shopper needs is at the heart of delivering the right medical solutions in the right way.

Join Abbott Laboratories, Bayer Healthcare, GlaxoSmithKline & Pfizer Consumer Healthcare and over 400 other best-in-class brands and retailers at the industry's most respected shopper insights event -

Shopper Insights in Action
July 11-14, 2010, Marriott Downtown Magnificent Mile, Chicago, IL
Download the brochure

Featured Consumer Healthcare Perspectives include:
Understanding Trip Segmentation & Shopper Insights to Increase Conversation & Build Traffic
- Mike Pishvanov, Associate Director, Shopper Insights, McNeil Consumer Healthcare
How Customers are Inspiring Brands through the Innovation Process via Online Communities
- GlaxoSmithKline & Communispace

Plus, learn from 100% of the 2010 Best in Shopper Marketing Excellence Brands:
1. UNILEVER: Mike Twitty, Director of Shopper Insights, Americas
2. PROCTER & GAMBLE: Lori Aulfinger, Consumer & Market Knowledge Director of the North America Retail Pillar
3. CONAGRA FOODS: Liz Mohr, Director of Shopper Insights & Analytics
4. KIMBERLY CLARK CORPORATION: Kim Leintz, Senior Manager, Marketing Research
5. NESTLE: Russ Onish, Director of Category Leadership & Shopper Insights
6. CAMPBELL SOUP: will be in attendance
7. CLOROX: will be in attendance
8. PEPSI: Ellen Furuya, VP of Center of Excellence and Michelle Laslo, Senior Manager, Shopper Insights
9. KRAFT FOODS: Autumn McDonald, Director In-Market Testing for Growth
10. THE COCA-COLA COMPANY: Jessica Ellickson, Director of Global Shopper Marketing
11. ABBOTT NUTRITION: will be in attendance
12. HORMEL FOODS (Tied for 12th): Bob Samples, Director of Category Planning & Support along with Bob Pepper, Group Manager of Simple Meals Team
12. Mars, Inc. (Tied for 12th): Marissa Sison, Ph.D., Director of Consumer and Market Insights

With over 50 sessions and more than 75 speakers, Shopper Insights in Action is the world's most comprehensive event focused on why we buy and how to take action. Don't miss out on learning how you can tap into the 360 degree sphere of influence. Download the brochure for full details!

We look forward to seeing you there.

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UAB Places emphasis on new Biorepository

The UAB Reporter Online looks at the new biorepository that was built in Birmingham, Alabama. There, scientists realize that the key to curing cancer and other diseases may lie within the body. The best way to find cures is to keep samples of all of the individuals who visit the biobank.

Human-tissue samples are vital to the scientific study of all diseases, especially cancer research, says Grizzle, a senior scientist in the Cancer Center. Scientists can compare gene profiles, DNA, clinical outcomes and other characteristics to locate and identify specific genes or mutations that routinely appear in cancers. That information enables doctors to identify patients who are more prone to cancer and select the most effective treatments.

Read the full article here.

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What's next for the Pharma industry?

The Atlantic has a very interesting article looking at the future of the Pharma industry. With most of the patents set to expire at the end of next year, many companies are also facing pipelines with few products and low approval rates from the FDA. With the clinical trials being the most expensive parts medical development, in addition to the targets of new drugs being very small portions of the population, many drugs are shelved or are out of financial reach for many of the patients who need to use them.

Pharmaceutical companies are blamed for focusing on marketing at the expense of innovation: they allegedly kill promising compounds because of fears of small markets, then concentrate on “me too” drugs that aren’t really any better than their competition’s. Or they tweak existing drugs in ways that don’t necessarily make the drugs any more effective, but do give companies a new patented drug for which they can charge the Earth.

Read the article here.

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Biosimilars are in demand from 1/3 of Pharma Market

According to a recent article at San Francisco City & Press, up to 1/3 of the Pharma market can have demand for biologics.

The opportunity presented to the biosimilars market with the article stating that “numerous biologic therapies with total revenues of $37B will have lost patent protection by 2017, promising considerable opportunity in biosimilars (government-approved new versions of branded biopharmaceutical products following patent expiration),”

Harry Glorikian, managing partner of Scientia Advisors, stated, “With the market for biologic* drugs growing much faster than that of drugs based on chemical compounds, pharmaceutical, biotechnology, generic drug and contract manufacturing companies are repositioning and forming new alliances in order to succeed in a rapidly changing landscape.”

Read the full article here.

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Drug Delivery Partnerships 2011 Industry Alert: Official Call For Presenters

From: Jennifer Sobrino, Conference Producer
Re: Call for Speakers & Presentations
Event Date: January 26-28, 2010
Event Venue: Doral Golf Resort & Spa, Miami, FL

SUBMIT YOUR PROPOSAL NOW!

The Institute for International Research (IIR) is currently seeking presenters for the 2011 15th Annual Drug Delivery Partnerships event. This 3-day event will take place January 26-28, 2011 in Miami, FL. We invite you to submit a proposal for a speaking opportunity directly to Jennifer Sobrino, by July 1, 2010. Please send to jsobrino@iirusa.com. Sessions will be 30-45 minutes including Q & A.

Submission Guidelines & Details

CUSTOMIZE YOUR CONFERENCE AGENDA!
We are currently recruiting drug delivery partnership executives who can share NEW DATA through detailed case studies related to leveraging the value of drug delivery to improve product pipelines, patient outcomes and boost innovation. This three day event will focus on current challenges the industry sees today and provide a forum for experts to come together and share knowledge and expertise.

Who will attend the leading industry conference on Drug Delivery Partnerships? Attendees will be both new and experienced drug delivery professionals in business development, technology, assessment & transactions, new product planning & development, R&D and more. We expect that the conference will attract between 400-500 attendees and are looking for novel approaches to handling drug delivery partnership issues including:

• Healthcare reform impact on reimbursement and innovation
• Drug delivery partnerships as a strategy for pipeline value creation
• Regulatory considerations
• Emergence of nanoparticulates as drug carriers
• Drug repurposing
• Innovation for OTC drugs
• Marketplace opportunities for biosimilars
• Regional preference for drug delivery methodologies in emerging markets
• Drug delivery focus in Latin America

MAKE SURE YOUR BIGGEST ISSUES ARE ADDRESSED!

Are your biggest concerns not addressed here? Contact Jennifer Sobrino at jsobrino@iirusa.com or 646.895.7310 to ensure that your pressing issue gets the attention it deserves!

Do you want to reach this audience?

We have a limited number of slots available for solution providers/consultants.
People who wish to become part of the program should contact, Sarah Scarry, Sponsorship Manager, at 646.895.7472 or sscarry@iirusa.com

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Q&A on Combination Products

I recently came across this white paper from Issac Medical Companies. It looks at various questions of combination products including:

-How do combination products work, and what advantages do they offer over other methods of drug delivery?
-How has the market arrived at the point where combination products are an important concept for the future of drug delivery?-How versatile are they in their applications?
-What scope is there to increase the range of applications in the future?

Read the white paper here.

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Omnitrope becomes first recommended biosimilar

The National Institute for Health and Clinical Excellence has recommended Omnitrope as the first biosimilar to be recommended for treatment. This biosimilar can be used in the treatment of growth failure in children.

Ameet Mallik, global head of Sandoz Biopharmaceuticals, stated:
"This is an important decision, the ramifications of which go far beyond the UK. Biosimilars, pioneered by Sandoz, are recognized around the world as having comparable safety, efficacy and quality to existing biopharmaceuticals following loss of patent protection.”

Read the full article here.

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