Tom Penrice

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Momentum for Biosimilars is Building. What’s Next?

Posted by Tom Penrice on Tue,Apr 23, 2013 @ 06:00 PM

Overview:
Both the FDA and the EMA are showing increasing levels of support for biosimilars, while physician resistance is declining in both the US and Europe. Cost is a big driver, among other factors.[1]

Biosimilar Drug Development Trends in Europe – Timing is Everything

Biosimilar drug development trends in US and European pharma drug development industryResistance to biosimilars in Europe is declining just as patents are expiring on many highly lucrative biologics, among them Herceptin (trastuzumab), Remicade (infliximab), and Rituxan (rituximab).  Significant cost advantages, important regulatory changes, and a growing openness to new methods of scientific analysis have combined to drive the trend.  Although the financial performance of biosimilars has been disappointing to date, nevertheless the perceived opportunities are attracting innovators and new players.

Why the Resistance to Lower Cost Biosimilars?

Resistance to date has been due primarily to two factors: pushback from physicians reluctant to switch patients to a biosimilar drug, and the lack of a systematic way for pharmacists to easily substitute a biosimilar for an originator drug.  As a result, the returns from biosimilars in Europe have been unimpressive to date. 

Meanwhile, in the US the FDA has yet to receive its first biosimilar application, despite the fact that for two years a regulatory pathway has been provided.  Innovator lobbying at the state level is a major factor contributing to the quagmire, whereby bills are being pushed to make it more difficult for automatic substitution of biosimilars for branded biologics to take place.

Doctors Signing On – Slowly

Unlike the FDA in America which has decision making power for all 50 states for such issues,  the EMA must leave it to each national government to make their own rulings on biosimilars.

In Norway, physicians are slowly growing more positive toward biosimilars partly due to price, a growing factor given sluggish European economies and rising health care costs, according to a cardiologist and medical director at Norway’s regulatory agency.

Economic incentives to prescribe cheaper drugs are also affecting physician acceptance of biosimilars in some northern European countries. For example, in Germany prescription quotas for generic drugs are imposed on physicians as a way to keep within allocated budgets. It is also helpful that Germany has declared copycat EPO’s to be the equivalent of the originals. Although not legally binding, these quotas in Germany have contributed to copycat EPO penetration growing from 30% to 39% in the past three years.[2]

Biosimilars - Impact on Price and Profits

The downward pressure on price due to the growing adoption of biosimilars has resulted in innovators making deep price cuts in order to retain market share, including with hospitals. As a result, payers are enjoying the savings.  Savings in Germany are estimated at over €1 billion per year by 2017.

Changing Definitions and Perceptions

EMA is increasingly accepting biosimilars due in part to recognizing that analytical science gains have made it possible to supply proof of similarity without requiring the time and expense of clinical data.  Last year EMU changed it’s description of biosimilars from products deemed “similar but not identical” to one stating, “the active substance of a biosimilar and the reference medicine is essentially the same biologic substance, though there may be minor differences”, thereby making it more difficult for innovators to make the case for their originals. 

FDA More Open to Biosimilars?

The FDA, while arriving late to the game, may be more open to biosimilars than EMA in terms of an easier acceptance of the analytical science argument for determining similarity. By comparison, the EMA appears to rely more on a clinical trial mindset. The US approach has not been without its rewards, as competition and savings can be significant. According to IMS Health, the US health care system has saved $1.6 billion since launch on Sandoz / Momenta Pharmaceuticals Inc.’s m-enoxaparin, the first of two competing complex copies of Sanofi’s Lovenox (enoxaparin).

Long Term Impact of Biosimilars on the Pharma & Biotech Industry

Now that payers are alert to the cost savings potential of biosimilars, there can be little doubt that the pressure to drive down prices will continue unabated. Indeed, the payers, especially the government payers, have the capability to change the game very quickly.

If prices and profits were to drop sharply and frequently for originals due to growing inroads made by biosimilars, one must wonder to what degree investment in research by innovators may suffer.


[2] http://www.elsevierbi.com/publications/the-pink-sheet/75/6/germany-may-need-to-jump-start-its-stagnant-biosimilars-market 


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Pharma Brand Strategy, FDA, Drug Developers, Biosimilars, Health Care Costs, EMA

FDA-Mixed Response to Proposed Faster Drug Development Pathway

Posted by Tom Penrice on Thu,Feb 07, 2013 @ 04:00 PM

Does the US Need Another Expedited Drug Development Pathway?

The FDA’s meeting to discuss a proposed new pathway aimed at expediting the development of “medicines intended to treat serious or life-threatening conditions with unmet medical needs”, met with a mixed response on February 4th.  The proposal was prompted by a report last fall from the US President’s Council of Advisors on Science and Technology(PCAST), which said a “special medical use”(SMU) pathway could improve drug evaluation in the US.

FDA receives mixed results on proposal for faster drug development pathwayThe Public Weighs In

Participants weighing in on the issue included representatives from Cubist Pharmaceuticals, Trius Therapeutics, Biotechnology Industry Organization, The National Research Center for Women & Families, and Antibiotics Working Group (AWG).

Is There a Need for an Alternate Drug Development Pathway?

Creating an alternative approval pathway could "greatly enhance" the prospects for successful clinical development of novel antimicrobials against the ESKAPE pathogens and would complement the GAIN Act's incentives (Generating Antibiotic Incentives Now (GAIN) Act).

However, there are already six other expedited drug development pathways in place and 50% of the medicines approved in 2009 and 2011 were through a priority pathway. Additionally, various other proposals from the anti-infective development community and the Infectious Diseases Society of America (IDSA) are already on the table, with an assortment of names and acronyms, such as "special population limited medical use" (SPLMU) and "limited population antibacterial drugs" (LPAD).

Some Concerns Brought to Light

There were a few concerns expressed during the discussion, including:

  • Could another expedited drug development pathway create potential congressional intervention resulting in added demands on the FDA?
  • If the FDA pursues its new alternative pathway, could the expedited approval pathways in the Food and Drug Administration Safety and Innovation Act, such as the breakthrough therapies designation, get short shrift?

Suggestions to Enhance Potential Advantages:

Suggestions made for enhancing the potential advantages of the proposal included:

  • Adopt a tiered regulatory framework for the new alternative regulatory pathway, which would allow either disease- or pathogen-based label indications, along with labeling that encourages the most appropriate use of the new medicines commensurate with the approved indications.
     
  • Expand the new initiative to include later stage products, and include indications for which there currently is no guidance, such as prosthetic bone and joint infections, osteomyelitis and bacteremia.
     
  • For antibacterials, the FDA's definition of unmet medical need should not only focus on current needs, but also future needs.
     
  • Balance the dual priorities of expediting clinical development through smaller and more targeted studies and use of authorities that promote responsible prescribing for specific sub-populations through appropriate labeling and restrictions of use.
     
  • Provide clarity about mechanisms or processes to expedite the clinical development of limited use products if it is to include postmarket restrictions of use.
     
  • Make any SMU designation available early in drug development so that manufacturer can design appropriate clinical studies for use under the pathway, for example by conducting trials based on only the most severe manifestation of the disease without having to progress through more moderate disease populations first.
     

You Decide

Is there a need for yet another expedited drug development pathway? As mentioned in our prior post, a streamlined clinical trial process for drug development could have significant strategic planning and competitive intelligence implications for pharmaceutical and biotech firms. Please share your thoughts.


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: FDA, Drug Development, Competitive Intelligence

FDA to Consider Faster Drug Development via Smaller Clinical Trials

Posted by Tom Penrice on Fri,Feb 01, 2013 @ 12:00 PM

FDA Hearing on Faster Clinical Trial Process

FDA considers faster drug development process. Implications for Pharma and Biotech Drug Development and Competitive Intelligence.In January the FDA announced it will be holding a public hearing on February 4 and 5, 2013 to gather input on what may lead to a faster clinical trial process for drug and biological products development for "serious or life-threatening conditions that would address and unmet medical need". If approved, an expedited drug development process will be permitted for smaller subpopulations of patients with "more serious manifestations" of a condition. Such a process will lead to faster clinical trials vs. typical studies involving a broader group of patients with a wide range of clinical manifestations.

New Labeling Required

Labeling for approved drugs under the proposed process must clearly show that the drug is "narrowly indicated for use in limited, well-defined subpopulations in which the drug's benefits have been shown to outweigh its risks." Labeling requirements may include an appropriate logo to appear on the container.

Obtaining Public Comments

The purpose of the public hearing is to obtain information and comments on the "need for and feasibility of this pathway and its potential advantages and disadvantages".

Other Highlights

The FDA recognizes that the resource-intensive programs required to approve drugs treating a "broad condition with a wide range of clinical manifestations" requires large study populations which can prevent a drugs from becoming available on a timely basis to patients with "important and unmet medical needs".

It is important to explore the benefits and feasibility of a drug development process for smaller sub-populations of patients with serious or life-threatening conditions, including infections caused by antibiotic-resistant bacteria.

The approval of a narrow indication could be broadened if future data demonstrate the effectiveness and safety in treating a "broader condition or patient population".

For further information, go to http://www.gpo.gov/fdsys/pkg/FR-2013-01-15/pdf/2013-00607.pdf

Impact on the Drug Development Industry

If approved, a streamlined clinical trial process for the development of drugs and biological products may have significant implications for pharmaceutical and biotech firms. Strategic planning and competitive intelligence will take on an added dimension. Forward-thinking strategists would do well to thoroughly consider the implications and the potential to gain a competitive advantage should approval be granted for an expedited drug development process.


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: FDA, Drug Development, Competitive Intelligence

Welcome to Pharma & Biotech Today

Posted by Tom Penrice on Mon,Jan 07, 2013 @ 04:59 PM

Welcome to Pharma & Biotech Today, the blog for pharmaceutical and biotechnology industry professionals. Our goal is to provide you with thought-provoking articles and opinions to assist you in moving your pharma or biotech firm to the forefront in today's competitive market and ever-changing landscape.

Trusted pharma and biotech consulting industry services for over 20 years - Pennside Partners.20 Years Experience -
A Wealth of Information to Share 

With over 20 years in the pharma and biotech consulting business, we have a wealth of information and experience to share with you, our valued readers and subscribers.

In the weeks and months ahead we plan to devote considerable energy to addressing key biotechnolgoy and pharmaceutical industry topics of interest, including:

    • Prelaunch and launch planning and best practices
    • Launch analogs
    • Business development
    • Brand strategy
    • Benchmarking
    • Competitive intelligence (CI) and monitoring
    • Pipeline analysis
    • Disease landscape
    • Licensing and acquisition
    • Market insight
    • ... and many more!

Pharmaceutical and Biotechnology consulting experts - Pennside PartnersWe Want to Hear From You!

Tell us about any topics that interest you in today's fast-paced and ever-changing pharma and biotech fields. We'll look forward to addressing many of them in upcoming articles. We'd love to hear from you soon - just click to contact us any time.

Finally, please bookmark this site and check back often for the latest in pharma and biotech news, information, and thought leadership. 


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Pharma Brand Strategy, Pharma Consulting, Biotech Consulting, Pharma Launch Planning, Competitive Intelligence, Pipeleine Analysis, Pharma Launch Analogs

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