Follitropin alfa biosimilar(Bridge Pharmaceuticals, Inc.)

CHICAGO, June 15, 2023 /PRNewswire/ -- The biosimilars industry is poised for significant growth and innovation in the near future. Biosimilars, which are highly similar and interchangeable versions of approved biologic drugs, offer several advantages such as increased patient access to affordable treatments, cost savings for healthcare systems, and enhanced competition in the pharmaceutical market. With the expiration of patents on several high-revenue biologic drugs, the biosimilars market is expected to expand rapidly as more companies enter the space. Advances in manufacturing technologies, analytical techniques, and regulatory frameworks will drive the development and commercialization of a broader range of biosimilars across therapeutic areas. This increased competition will further drive down prices, making life-saving biologic treatments more accessible to patients worldwide. Additionally, collaborations between biosimilar manufacturers, healthcare providers, and regulatory authorities will help build confidence in the safety, efficacy, and quality of biosimilars, fostering their widespread adoption. As the biosimilars industry matures, it will not only reshape the pharmaceutical landscape but also play a pivotal role in addressing the growing healthcare demands and improving patient outcomes on a global scale. Biosimilars Market in terms of revenue was estimated to be worth $29.4 billion in 2023 and is poised to reach $66.9 billion by 2028, growing at a CAGR of 17.8% from 2023 to 2028 according to a new report by MarketsandMarkets™. Major factors driving the market growth at significant CAGR are rising incidence of chronic diseases and increasing demand of biosimilars. Furthermore, increased number of approvals and investment in research and development of biosimilars is likely to upsurge the market growth in coming years. Download an Illustrative overview: Browse in-depth TOC on "Biosimilars Market" 216 - Tables 49 - Figures 306 - Pages Biosimilars Market Scope: Monoclonal Antibodies accounted for the largest share of the drug class segment in the biosimilars market in 2022. Based on the drug class, the biosimilars market is segmented into monoclonal antibodies, insulin, granulocyte colony-stimulating factor, erythropoietin, recombinant human growth hormone, etanercept, follitropin, teriparatide, interferons, anticoagulants and other drug class. The monoclonal antibodies product segment accounted for the largest share. It is expected to dominate the market throughout the forecast period. Declining of the monoclonal antibodies biosimilars owing to increased competition is likely to have positive impact on the market growth. Rising prevalence of cancer is also one of the major factor increasing demand of mabs is boosting growth of the segment. The oncology segment accounted for the largest share of the indication segment in the biosimilars market in 2022. Based on the indication, the biosimilars market is segmented into oncology, inflammatory and autoimmune diseases; chronic diseases, blood disorders; growth hormone deficiency; infectious diseases and other indications. Oncology accounted for the largest share of the market in 2022. Rising incidence of cancer coupled with increased demand for the cost effective biosimilars is driving the segmental growth. Furthermore, increased research and huge number of products under clinical trials is further expected to project growth at faster pace. Asia Pacific is likely to grow at the highest growth rate during the forecast period. Based on the region, the global biosimilars market is segmented into North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa. Europe is the largest regional segment followed by Asia Pacific. The Asia Pacific region is estimated to grow at the highest CAGR in the biosimilars market during the forecast period. The emergence of new players the market, increased approvals for biosimilars in the region and loss of patent exclusitivity are some of the major factors propelling the market in Asia Pacific region. Request Sample Pages: Biosimilars Market Dynamics: Drivers: Increasing demand for biosimilars Launch of novel biosimilars Rising geriatric population and chronic disease incidence Abbreviated regulatory approval process and interchangeability Restraints: Complexities in manufacturing Opportunities: Emerging markets Patent expiries of blockbuster biologics and research into new indications Challenges: High competition and regulatory challenges Key Market Players: Some of the prominent players in the biosimilars market are Novartis AG (Switzerland), Pfizer, Inc. (US), Dr. Reddy's Laboratories Ltd. (India), Amgen, Inc. (US), Eli Lilly and Company (US), and among others. Get 10% Free Customization on this Report: Recent Developments: In January 2023, Amgen Inc. launched AMJEVITA (adalimumab-atto), a biosimilar to Humira (adalimumab) in United States In October 2022, Biocon and Yoshindo Inc., entered into an agreement for commercializing Biocon’s pipeline products ustekinumab and bDenosumab in Japan Biosimilars Market Advantages: Increased Access to Affordable Treatment: Biosimilars provide a more cost-effective alternative to expensive biologic drugs. By offering comparable efficacy and safety profiles at a lower price, biosimilars expand patient access to essential treatments. This is particularly significant in the case of chronic diseases where biologics play a vital role but may be financially burdensome for patients and healthcare systems. Cost Savings for Healthcare Systems: The introduction of biosimilars creates competition in the pharmaceutical market, leading to reduced prices for both biosimilars and reference biologics. This drives down healthcare costs and allows for more efficient allocation of resources within healthcare systems. The cost savings generated by biosimilars can be redirected towards improving access to other medical interventions or expanding healthcare services. Market Competition and Innovation: Biosimilars foster competition among pharmaceutical companies, encouraging innovation and the development of new therapeutic options. As more manufacturers enter the biosimilars market, it stimulates research and development efforts to improve manufacturing processes, enhance product quality, and explore novel therapeutic applications. This competition ultimately benefits patients by expanding treatment options and promoting continuous advancements in biologic therapies. Regulatory Framework and Quality Standards: The biosimilars market is supported by robust regulatory frameworks that ensure the safety, efficacy, and quality of these products. Stringent regulations guide the development, manufacturing, and approval processes of biosimilars, ensuring they meet rigorous standards and are comparable to reference biologics. This provides healthcare professionals and patients with confidence in the reliability and performance of biosimilars. Healthcare Sustainability and Patient Outcomes: The increasing adoption of biosimilars contributes to the long-term sustainability of healthcare systems. By reducing the financial burden associated with expensive biologic drugs, biosimilars enable healthcare providers to allocate resources more efficiently, ensuring that patients have access to vital treatments. This, in turn, can lead to improved patient outcomes, better disease management, and enhanced overall healthcare effectiveness. The biosimilars market's advantages, including increased access to affordable treatment, cost savings, market competition and innovation, robust regulatory frameworks, and improved healthcare sustainability, make it a promising sector that can address unmet medical needs and drive positive change in healthcare systems globally. Biosimilars Market – Report Highlights: Key conferences, and events 2022-2023, key stakeholders & buying criteria, pipeline analysis and trends/ disruptions impacting customer business are added in the market overview chapter. The new edition of the report provides updated financial information till 2022 (depending on availability) for each listed company in a graphical representation. This would help in the easy analysis of the present status of profiled companies in terms of their financial strength, profitability, key revenue-generating region/country, and business segment focus in terms of the highest revenue-generating segment. Impact of the recession has also been added in the new addition of the report. Recent developments are helpful to understand market trends and growth strategies adopted by players in the market. Tracking product portfolios of prominent market players helps to analyze the major services in the biosimilars market. The new edition of the report provides an updated service portfolio of the companies profiled in the report. Market evaluation framework, market share analysis, and competitive leadership mapping have been added in the competitive landscape chapter of the report. The competitive leadership mapping has been updated considering recent developments in the company evaluation matrix. Related Reports: Proteomics Market - Global Forecasts to 2028 Biologics Safety Testing Market - Global Forecasts to 2027 Protein Expression Market - Global Forecasts to 2027 Protein Characterization Market - Global Forecasts to 2026 Pen Needles Market - Global Forecasts to 2026 About MarketsandMarkets™: MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. We have the widest lens on emerging technologies, making us proficient in co-creating supernormal growth for clients. The B2B economy is witnessing the emergence of $25 trillion of new revenue streams that are substituting existing revenue streams in this decade alone. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines - TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing. Built on the 'GIVE Growth' principle, we work with several Forbes Global 2000 B2B companies - helping them stay relevant in a disruptive ecosystem. Our insights and strategies are molded by our industry experts, cutting-edge AI-powered Market Intelligence Cloud, and years of research. The KnowledgeStore™ (our Market Intelligence Cloud) integrates our research, facilitates an analysis of interconnections through a set of applications, helping clients look at the entire ecosystem and understand the revenue shifts happening in their industry. To find out more, visit ™.com or follow us on Twitter, LinkedIn and Facebook. Contact: Mr. Aashish Mehra MarketsandMarkets™ INC. 630 Dundee Road Suite 430 Northbrook, IL 60062 USA: +1-888-600-6441 Email: [email protected] Research Insight: Visit Our Website: Content Source: Logo: SOURCE MarketsandMarkets

PROFILE is the first prospective, multi-national, observational, real-world study of Rekovelle in clinical practice, conducted in more than 940 women from 10 countries across Europe, North America and Australia. This study provides evidence of the effectiveness of Rekovelle across a broad range of patients in a real-world clinical setting and supports its efficacy and safety profile, as previously demonstrated in randomised controlled trials (RCTs). 1-4 In the study, 74.0% of patients had between 4 and 19 oocytes retrieved and the ongoing pregnancy rates were similar to Phase 3 RCTs.1-3 Rekovelle is the only recombinant follicle-stimulating hormone (rFSH) for ovarian stimulation (OS) that uses individualised dosing calculated through an approved algorithm based on bodyweight and anti-Müllerian hormone (AMH) levels. SAINT-PREX, Switzerland--(BUSINESS WIRE)-- Today, an oral poster of the first post-authorisation Phase 4 real-world study, PROFILE, is being presented at the 13th Congress of the Pacific Society for Reproductive Medicine (PSRM) 2023 in Australia. The large, prospective, multi-national study confirms the effectiveness and safety of Rekovelle in routine clinical practice, with ongoing pregnancy rates similar to Phase 3 RCTs.1-3,5 The study was first published in Frontiers of Endocrinology in December 2022.5 The PROFILE study enrolled 944 women who had not previously undergone in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). Results highlighted that with Rekovelle, almost three-quarters (74.0%) of women had between 4-19 oocytes retrieved and 255 women (27.0%) achieved an ongoing pregnancy at 10-11 weeks after transfer. The ongoing pregnancy rate was similar to the rates observed in the Phase 3 RCTs.1–3 The first cycle cumulative ongoing pregnancy rate after fresh and/or frozen transfer was 36.4%. The research also showed a 3.9% incidence of ovarian hyperstimulation syndrome (OHSS), with most cases of OHSS being of mild to moderate intensity, (n=30 [3.2%]) and all participants with OHSS made a full recovery.5 “Up to now, we have more than 2,000 patients in the RCTs for Rekovelle – ESTHER-1 and -2, GRAPE and STORK trials – but these had strict inclusion and exclusion criteria. Real-world data extends efficacy and safety data to all patients. In fact, in PROFILE there were nearly no restrictions other than that the participants were seeking to become pregnant, had no contraindications to rFSH, and had not previously undergone ovarian stimulation,” said Professor Christophe Blockeel, from Brussels IVF, the Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel and Vrije Universiteit Brussel, who was the principal investigator of the PROFILE study. In countries where it is licensed, Rekovelle is the only rFSH for OS that has an individualised fixed daily dose calculated using an approved algorithm based on bodyweight and levels of AMH. AMH is a biomarker used to predict ovarian response.6 In PROFILE, physicians used the Rekovelle dosing algorithm for nearly all participants (95%), although some made minor adjustments to the prescribed starting dose or adjusted the dose during OS based on clinical factors. Adverse drug reactions (ADRs) were monitored for all initiated OS cycles, and the number of ADRs leading to treatment and study discontinuation was low (n=4). “Ferring is committed to building healthy families of every shape and size by developing innovative fertility treatments. We are committed to seeking insights throughout the research and development of our treatments, so it is therefore encouraging to see that in an observational study of real-world clinical practice, Rekovelle confirmed its effectiveness through ongoing pregnancy rates, similar, or higher than RCTs,” said Christina Lloyd, Senior Vice President and Head of Reproductive Medicine and Maternal Health, Ferring Pharmaceuticals. - ENDS - About the PROFILE study In the PROFILE study (Prospective multicentre non-interventional study to assess the patterns of use of Rekovelle in women undergoing in vitrO Fertilisation or Intracytoplasmic sperm injection procedures in routine clinicaL practicE), 1,258 women were screened between March 2018 and October 2020, and 1,013 met the inclusion and exclusion criteria. A total of 944 participants initiated their first OS cycle at 34 specialist fertility clinics across Australia, Austria, Belgium, Canada, Germany, Italy, Netherlands, Poland, Spain and UK in which Rekovelle is licensed. The primary endpoint was the real-world treatment patterns of follitropin delta, including starting daily dose, number of days of treatment, deviations from the approved dosing schedule as per the summary of product characteristics (per-label), use of dosing algorithm, and use of other treatments during OS, such as GnRH protocol, triggering methods of follicle maturation and luteal phase support. Secondary endpoints included cycle cancellations, pregnancy outcomes for Cycle 1, and OHSS and other ADRs for all initiated cycles. Participants could initiate up to three OS cycles with Rekovelle; however, utility and effectiveness data were only analysed for Cycle 1 as the study was terminated early due to the COVID-19 pandemic, during which many fertility clinics closed or provided reduced services. Real-World Utilisation Patterns of Rekovelle The study aimed to observe the real-world utilisation patterns, effectiveness, and safety pro follitropin delta in women ≥18 years naïve to OS undergoing IVF or ICSI. According to the data collected during the study, most participants received Rekovelle as specified in the approved label without dose deviations. In PROFILE, nearly all patients (95%) had their starting dose calculated using the algorithm, although some physicians then made minor adjustments to the prescribed starting dose during the OS cycle based on clinical factors. “We wanted to know if physicians are really using the dosing algorithm, and the answer is yes, the vast majority did. I think this really reflects how Rekovelle is being used in the real world and physicians are using the algorithm in those countries where it is approved,” said Professor Blockeel. In PROFILE, the mean total dose of follitropin delta was slightly higher than observed in randomised clinical trials, reflecting differences in bodyweight and AMH levels of the participants.1-5 The PROFILE study had no enrolment restrictions for bodyweight or AMH levels, and the overall study population had a higher mean bodyweight and had lower or comparable median AMH levels than the RCT cohorts.1-3,5 Adverse Drug Reactions ADRs were monitored for all initiated OS cycles (1,130 cycles for 944 participants). Forty-nine participants (5.2%) reported 58 ADRs. The number of ADRs leading to treatment and study discontinuation was low (four participants experiencing six ADRs: OHSS, n=2 events; vomiting, n=1 event; headache, n=1 event; rash, n=1 event and premature ovulation, n=1 event). The most frequent ADR was any grade of ovarian hyperstimulation syndrome (OHSS; n=37 [3.9%]), which was similar to the incidence of OHSS in the Rekovelle arm during the first cycle of the RCT ESTHER-1 (3.5%).1 In the PROFILE study, most cases of OHSS were of mild or moderate intensity (n=30 [3.2%]) and all participants with OHSS made a full recovery. About Rekovelle (follitropin delta) Rekovelle is a human rFSH with an approved dosing algorithm designed for a predictable ovarian response.7 It is the first rFSH derived from a human cell line (PER.C6® cell line). Rekovelle is structurally and biochemically distinct from other existing rFSH gonadotrophins.7, 8 Rekovelle is approved in certain markets for use in OS for induction of the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as IVF or ICSI. The individualised dosing of Rekovelle is determined using an approved algorithm, based on a woman’s AMH level and body weight.7-9 AMH is a biomarker used to assess ovarian reserve and can help predict ovarian response.6 The Rekovelle dose should be based on AMH level, measured using the ELECSYS AMH Plus immunoassay from Roche, the ACCESS AMH Advanced from Beckman Coulter, or LUMIPULSE G AMH from Fujirebio.7 Rekovelle is not approved in all markets. About Ferring Pharmaceuticals Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately-owned Ferring employs over 7,000 people worldwide. The company has operating subsidiaries in more than 50 countries and markets its products in over 100 countries. Learn more at , or connect with us on Twitter, Facebook, Instagram, LinkedIn and YouTube. References 1. Nyboe Andersen A, Nelson SM, Fauser BC, Garcia-Velasco JA, Klein BM, Arce JC, et al. Individualized versus conventional ovarian stimulation for in vitro fertilization: a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertil Steril. 2017 Feb;107(2):387-96 e4. PubMed PMID: 27912901. Epub 2016/12/04. 2. Qiao J, Zhang Y, Liang X, Ho T, Huang HY, Kim SH, et al. A randomised controlled trial to clinically validate follitropin delta in its individualised dosing regimen for ovarian stimulation in Asian IVF/ICSI patients. Hum Reprod. 2021 Jun 28;36(9):2452-62. PubMed PMID: 34179971. Epub 2021/06/29. 3. Ishihara O, Arce JC, Japanese Follitropin Delta Phase 3 Trial G. Individualized follitropin delta dosing reduces OHSS risk in Japanese IVF/ICSI patients: a randomized controlled trial. Reprod Biomed Online. 2021 May;42(5):909-18. PubMed PMID: 33722477. Epub 2021/03/17. 4. Bosch E, Havelock J, Martin FS, Rasmussen BB, Klein BM, Mannaerts B, et al. Follitropin delta in repeated ovarian stimulation for IVF: a controlled, assessor-blind phase 3 safety trial. Reprod Biomed Online. 2019 Feb;38(2):195-205. PMID: 30594482. Epub 2018/12/14. 5. Blockeel C, Griesinger G, Rago R, Larsson P, Sonderegger YLY, Rivière S, et al. Prospective multicenter non-interventional real-world study to assess the patterns of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study). Frontiers in Endocrinology. 2022 Dec 22;13:992677. PMID: 36619578. 6. Arce JC, La Marca A, Mirner Klein B, Nyboe Andersen A, Fleming R. Antimullerian hormone in gonadotropin releasing-hormone antagonist cycles: prediction of ovarian response and cumulative treatment outcome in good-prognosis patients. Fertil Steril. 2013 May;99(6):1644-53. PubMed PMID: 23394782. Epub 2013/02/12. 7. Follitropin Delta (Rekovelle) Summary of Product Characteristics. Date of publication 2016. Approved on 12 December 2016 and last updated on the EMA website in March 2022. Available from [Accessed March 2023]. 8. Olsson H, Sandstrom R, Grundemar L. Different pharmacokinetic and pharmacodynamic properties of recombinant follicle-stimulating hormone (rFSH) derived from a human cell line compared with rFSH from a non-human cell line. J Clin Pharmacol. 2014 Nov;54(11):1299-307. PubMed PMID: 24800998. Epub 20140521. 9. Arce JC, Andersen AN, Fernandez-Sanchez M, Visnova H, Bosch E, Garcia-Velasco JA, et al. Ovarian response to recombinant human follicle-stimulating hormone: a randomized, antimullerian hormone-stratified, dose-response trial in women undergoing in vitro fertilization/intracytoplasmic sperm injection. Fertil Steril. 2014 Dec;102(6):1633-40 e5. PubMed PMID: 25256937. Epub 2014/09/27. ### View source version on businesswire.com: Contacts For more information, please contact Amy Cheshire Director, Corporate Communications Amy.Cheshire@ferring.com Samara Barr Account Manager, Syneos Health Communications PR Europe +44 (0)7935 076261 (mobile) Samara.Barr@syneoshealth.com Source: Ferring Pharmaceuticals View this news release online at: