The Future of Biobetters
Strategies for success in the biobetter market
How can you successfully position biobetter products in the increasingly crowded branded biologic/biosimilar space?
With the prospect of improving patient adherence, meeting unmet clinical need and increasing revenues, investment in the biobetter pipeline has grown rapidly. Yet biobetter products need to bring some serious clinical and cost saving advantages if they are to get stakeholder support and make a return on investment. Success depends on navigating an undefined regulatory pathway, avoiding IP minefields and ultimately persuading stakeholders that the benefits are worth the cost.
In The Future of Biobetters, senior industry experts from leading pharma companies and organisations identify the challenges facing this emerging sector and provide practical and actionable insights for achieving commercial success.
Unique insights from US and EU experts in companies such as Takeda, Eisai and MedImmune
Table showing the technologies that can be applied in biobetter development
Graph illustrating EU5+US sales of key biologics scheduled to lose patent protection in 2015-2020
Chart demonstrating how biobetter development requires more analytical capabilities versus originator biologic development
Case Study: Developing a biobetter before an originator’s patent expiry: lessons from Roche
Case Study: Pulling potential biobetters out of the freezer: Takeda Oncology using advanced technology to reinvigorate a failed biologic projects
Case Study: Competition between biobetters: Amgen and Teva go head-to-head
Case Study: How overpricing of biobetters can make stakeholders lose trust in a company: Vertex Pharmaceuticals Orkambi experience
At-a-glance summaries of all the key takeaways.
Identify the advantages of biobetters, the value they present, and their competitive position in the branded biologic/biosimilar market
Examine how biobetters can meet unmet clinical need and improve patient outcomes
Understand the current regulatory situation and how this is impacting biobetter development
Investigate potential intellectual property issues that may challenge the sector
Critically appraise biobetter pricing and identify factors that will deliver optimum returns
Assess the potential for advances in technology and analytical tools to reinvigorate previously failed biologic projects
What’s in a name?
No one can agree exactly what a biobetter is. For some, it is a better safety profile, for others it is improved formulations and dosages that improve patient convenience and compliance. Biosuperior protein therapeutics is a definition preferred by others. Despite being sandwiched between originator biologics and biosimiliars, and with no standardised regulatory definition, the biobetter sector is carving out a significant market niche and attracting considerable investment and interest.
Key Questions Answered By This Report
Biobetters: what does “better” actually mean?
Timing: when is the optimum time to launch a biobetter for maximum market traction?
Targeting: What are the therapy areas of high unmet clinical need for biobetters to target?
Pricing: What are the critical clinical and patient benefits biobetters must have to command wide adoption and premium prices?
Old dog, new trick: How did Millennium Pharmaceuticals (Takeda Oncology) use advanced technology to create Entyvio (vedolizumab) from a previously failed biologic research project?
IP minefield: What IP issues should developers of biobetters be alert to?
Regulation: How is the lack of a standardised definition and regulatory guidelines negatively impacting biobetter sector progress?
Each industry expert has been carefully selected for their practical experience and detailed current knowledge of the biobetter sector.
Durgaprasad Annavajjula serves as the Senior Vice President of Stelis Biopharma in the Bengaluru area of India. He is a biopharma research and development senior leader and scientist, with over 25 years of extensive experience in R&D of biopharmaceuticals
Manfred Kurz is responsible for Global Regulatory Affairs (EU) development at Eisai EMEA, based in the UK. He manages the development and regulatory approval of new anti-cancer medicines
Dr. Matt Cooper is the Business Development & Marketing Director at the National Institute for Health Research (NIHR,) Clinical Research Network (CRN), Coordinating Centre in the UK
Phil Morton, Science Director of Bioprocess Characterisation with Albumedix, in the UK, has over 20 years experience in the biopharmaceutical industry within process and product development
Dr. T. Shantha Raju currently holds the position of Senior Director at MedImmune, Maryland, as the Head of Global Bioassay and Quality. His most significant contribution is his research conducted to develop leading cancer therapeutics, such as Rituxan, Herceptin, Avastin, Remicade, and Simponi
Theresa O’Keefe is the Chief Scientific Officer and Co-Founder at Mend Therapeutics in Massachusetts. Dr. O’Keefe has over 15 years of biotechnology and pharma drug development experience, as well as 10 years in academic research
Oleksandr Karpenko, Consultant Global Safety Lead (Medical Director) based at Takeda Pharmaceuticals in London.
Anonymous. After having worked for over 20 years in a major pharmaceutical company that developed biobetters, this contributor is now a Director of an International Consultancy company on Biopharmaceuticals
Anonymous. The analytics lead at a leading biopharmaceutical company.
3 Key Quotes
“If the company developing the biobetter has correctly identified the unmet need associated with the originator, and the unmet need is seen as a significant failing by either the healthcare provider or the patients, then biobetters can be seen as a significantly differentiated product. Market share will depend very much on the improvements and safety profile of the biobetter versus the originator. If these are significant then it may be possible to take a very high market share.”Phil Morton, Science Director of Bioprocess Characterisation at Albumedix
“For example, a patient may be given a once-daily biologic in the first line therapy, a choice that is made because the biologic is well established and has a long history of use. If the first line biologic does not work, it will be unlikely that patients will be given the biobetter version since it has the same mechanism of action. As such, unless the biobetter offers enough to displace the use of the innovator original, then it will be a commercial struggle” Anonymous,Analytics Lead at a leading biopharmaceutical company
“They are two different businesses. Their target markets and pricing strategies can differ. In the biosimilar business, the main criterion is to increase the treatment accessibility by reducing the cost. Emerging markets and the Rest-of-the-World are the markets that biosimilars have good potential to grow, whereas regulated markets such as the US, Europe, Japan, Australia and New Zealand have good potential for biobetters. There is a business opportunity for both, separately” Durgaprasad Annavajjula ,Senior Vice President at Stelis Biopharma
Who Would Benefit from This Report?
Managers planning biobetter development programmes
HEOR teams building evidence of value for biobetter therapies
MSL teams needing to demonstrate the clinical advantages of biobetters to physicians
Commercial teams negotiating price and formulary position with payers
Regulatory professionals needing to navigate the as yet undefined submission and review pathways
Research managers designing biobetter clinical trials
Corporate managers needing to make strategic investment decisions in the biobetter market
Executive Summary & Experts interviewed
The emergence of biobetters
The biosimilar struggle
Biobetters vs. biosimilars
The biobetter advantage
Marketing acceptance of biobetters
Expanding treatment options
Delivering convenience to patients
The risk for increased safety issues
Formulary preference for cheaper biologic alternatives
The implications of competing with originators and biosimilars
Biobetters versus originators
An opportunity to lower healthcare cost versus originators
An opportunity to generate manufacturing efficiency and quicker time-to-market for drug developers
More robust pre-trial analytical capabilities are required
Biobetters versus biosimilars
Competing in terms of price will be a challenge
Addressing different patient types and populations
Timing the market entrance of a biobetter with respect to biosimilars
Challenges in biobetter development and uptake
Lack of a standardised definition and regulatory guidelines
The potential rise of intellectual property (IP) issues and competitor biobetters
The impact of market perception on clinical trial recruitment
Limited resources and the pressure to excel in the market
Putting a price on the value of biobetters
The issue of expensive pricing
A premium price for significant improvements in efficacy and safety
Lowered cost and other considerations during the valuation process
Strategies for future opportunities in the biobetter space
Seeking to address an unmet need
Mapping the safety data and the clinical trial design
Partnerships with biotech firms and research organisations
Early engagement with stakeholders: KOLs, Clinicians and Payers
Predictions for biobetter development
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