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
- Introducing biobetters
- Biobetters vs. biosimilars
- The biobetter advantage
Marketing acceptance of biobetters
- Key Insights
- 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
- Key Insights
- 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
- Key Insights
- 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
- Key Insights
- 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
Table of Contents
3.The landscape of biological medicines
- 3.1. The case for biological alternatives
- 3.2. Introducing biobetters
- 3.3. Biobetters vs. biosimilars
- 3.4. The biobetter advantage
4. Marketing acceptance of biobetters
- 4.1. Key Insights
- 4.2. Expanding treatment options
- 4.3. Delivering convenience to patients
- 4.4. The risk for increased safety issues
- 4.5. Formulary preference for cheaper biologic alternatives
6. The implications of competing with originators and biosimilars
- 6.1. Key Insights
- 6.2. Biobetters versus biologics
- 6.2.1. An opportunity to lower healthcare cost versus originators
- 6.2.2. An opportunity to generate manufacturing efficiency and quicker time to-market for drug developers
- 6.2.3. More robust pre-trial analytical capabilities are required
- 6.3. Biobetters versus biosimilars
- 6.4. Competing in terms of price will be a challenge
- 6.5. Addressing different patient types and populations
- 6.6. Timing the market entrance of a biobetter with respect to biosimilars
7. Challenges in biobetter development and uptake
- 7.1. Key Insights
- 7.2. Lack of a standardised definition and regulatory guidelines
- 7.3. The potential rise of issues relating to intellectual property (IP)
- 7.4. The impact of market perception on clinical trial recruitment
- 7.5. Limited resources and the pressure to excel in the market
8. Putting a price on the value of biobetters
- 8.1. Key Insights
- 8.2. The issue of expensive pricing
- 8.3. A premium price for significant improvements in efficacy and safety
- 8.4. Lowered cost and other considerations during the valuation process
9. Future opportunities in the biobetter space
- 9.1. Key Insights
- 9.2. Seeking to address an unmet need
- 9.3. Mapping the safety data and the clinical trial design
- 9.4. Partnerships with biotech firms and research organisations
- 9.5. Early engagement with stakeholders
- 9.5.1. KOLs
- 9.5.2. Clinicians
- 9.5.3. Payers
10.Predictions for biobetter development