BioPharm International - October 2021

BioPharm-October 2021-Regulatory-Sourcebook

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Page 16 of 33 October 2021 eBook BioPharm International 17 techniques, wh ich enta i ls a focus on analy tic techniques and the use of artif icial intelligence or data sci- ences to enable innovation, as well as a decrease in regulation, which may be a precursor to an increasingly unique biosimilar licencing process." As already covered, the key dif- ferences bet ween the UK and EU guidelines are the need for UK ref- erence products, the lack of require- ment for in-vivo studies in animals, and changes in the requirement for a comparative eff icacy trial in most cases, summarizes Marton. "I believe changes to the requirements on stud- ies were needed, ref lecting the expe- riences of MHRA and EU medicine authorities over the years," she says. "Similar changes can be expected at an EU level as a result of legislative updates under the 'Pharmaceutica l strategy for Europe' proposal." FUTURE ADVANCEMENTS "Over the next period we can expect t o s e e m o r e bio s i m i l a r s a c c e s s- i ng Eu rop ea n ma rk ets a s ma rk et e xc lusiv it y a nd a l most a l l patents will expire by 2029. But it remains to be seen how appealing it will be for manufacturers to start develop- ing biosimilars," states Marton. "I hope that legislative changes driven by the 'Pharmaceutical strateg y for Europe' will ref lect the experiences of the authorities up to now and cre- ate a clearer and more relaxed legisla- tive framework for biosimilars." For Manley, there is an expectation that regulatory scrutiny of biosimilars should lessen in the long-term in the UK, as a result of the adjustments to the regulatory approach being implemented by MHRA. The EU is unlikely to expe- rience any drastic change as the biosim- ilar development program in Europe is already successful, she adds. "The rate at which biosimilars are being approved is increasing, suggest- ing a bright future for the regulatory landscape of biosimila rs," Manley states. "This, along with the general enthusiasm about the development of biosimilars, could encourage companies to invest more strongly in their biosim- ilar research and manufacturing." However, new entrants to the bio- similar manufacturing market will be faced with existing challenges, such as establishing comparability and process validation, Manley continues. "Thus, in order to encourage more innova- tion, regulatory approaches may have to bear [these hurdles] in mind so as not to stymie the development of new biosimilar products," she says. "As more knowledge is generated on biosimilar products, and more data from patients becomes available, more conf idence will be gained from the long-term use of biosimilars," declares Lanucara. " This [increased k nowl- edge] will hopefully result in a more standardized approach to the defini- tion of the core of quality, safety, and eff icacy aspects for each biosimilar product class, thus leading to simpli- f ied approval pathways and stream- lined development approaches." Furthermore, although the cost of biosimilar manufacturing is high, as reg u lator y approva ls become more streamlined, faster, and cost-effective, there will be an inevitable drive for more biosimilar medicines to enter the market, Lancaster notes. With increased competition, it is expected that prices would be lowered, help- ing to reduce costs for healthcare sys- tems—a huge incentive following the COVID-19 pandemic, he adds. "However, while facilitating com- petition reduces costs for healthcare systems, the f lip side is potentially increased price erosion and reduced prof its. Some generic medicines are subject to rapid price erosion when they go off-patent. Although the mar- ket dynamics with biosimilars are dif- ferent, the nature of the regulator y framework clearly has an important role in ensuring a long-term incentive to invest in biosimilar medicines." As more data become available and cost pressures increase on national hea lt h ser v ices, t he l ikel ihood of switching bet ween a biosimilar and originator product w il l be greater, states Lancaster. Increased com- petition could also prompt national regulators to assess whether switch- ing patients from one biosimilar to another should be allowed. "Regulators will be aware of the need to balance all of these issues, and it will be interesting to see how t he reg u l ator y proce s se s for bio- similar medicines across the globe evolve over the next decade," con- cludes Lancaster. REFERENCES 1. PharmaLex, "EMA Guidance on Biosimilars in the EU," Press Release, Nov. 25, 2019. 2. GaBi Online, "Biosimilars Approved in Europe," Article, Last Updated Feb. 12, 2021. 3. IMARC, Biosimilar Market in Europe: Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2021–2026, Market Report, May 2021. 4. Vikram, A. Deep, and Manita, Appl. Clin. Res. Clin. Trials Regul. Aff., 6 (3) 192–211 (2019). 5. EC, Commission Directive 2003/63/ EC of 25 June 2003 Amending Directive 2001/83/EC of the European Parliament and of the Council on the Community Code Relating to Medicinal Products for Human Use (Brussels, Belgium, June 25, 2003). 6. EC, Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 Amending Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use (Strasbourg, France, March 31, 2004). 7. EMA, Guideline on Similar Biological Medicinal Products, Guidance Document, Oct. 23, 2014. 8. M. Schiestl, M. Zabransky, and F. Sörgel, Drug Des. Devel. Ther., 11, 1509–1515 (2017). 9. EMA, Ref lection Paper on Statistical Methodology for the Comparative Assessment of Quality Attributes in Drug Development, Guidance Document, July 26, 2021. 10. MHR A, Guidance on the Licensing of Biosimilar Products, Guidance Document, May 6, 2021. BP Regulatory Sourcebook Biosimilars

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