Alvotech and Dr. Reddy’s enter into collaboration for commercialization of AVT03 (denosumab), a biosimilar candidate to Prolia® & Xgeva® in the U.S., Europe and UK
Alvotech and Dr. Reddy's have entered a collaboration to commercialize AVT03, a biosimilar to Prolia® and Xgeva® (denosumab), in the US, Europe, and the UK. Dr. Reddy's will have exclusive commercialization rights in the US and semi-exclusive rights in Europe and the UK. Alvotech will handle the development and manufacturing of AVT03. The agreement includes upfront, milestone, and sales-based payments to Alvotech. Erez Israeli, CEO of Dr. Reddy's, emphasized the strategic importance of this collaboration in expanding their biosimilar portfolio. Robert Wessman, Chairman and CEO of Alvotech, highlighted the partnership's potential to improve global access to affordable biologic medications.
- Dr. Reddy's gains exclusive commercialization rights in the US and semi-exclusive rights in Europe and the UK.
- Alvotech receives upfront payments, milestone payments, and sales-based payments.
- Strategic collaboration enhances Dr. Reddy's biosimilar portfolio in highly regulated markets.
- Potential to increase global access to cost-effective biologic medications.
- The agreement's financial terms, such as the exact amounts for upfront and milestone payments, are not disclosed, which may cause uncertainty for investors.
- There might be potential regulatory hurdles in gaining approval for the biosimilar in various markets.
Insights
Dr. Reddy's partnering with Alvotech to commercialize AVT03, a biosimilar to Prolia® and Xgeva®, is strategically significant. Biosimilars are gaining traction as cost-effective alternatives to original biologic drugs, presenting substantial market opportunities. Prolia® and Xgeva® are well-established treatments, generating substantial revenue. If AVT03 secures regulatory approvals, it could capture a share of this lucrative market.
The arrangement includes
Short-term, the agreement should boost investor confidence in both companies due to the immediate financial benefits and strategic alignment. Long-term, successful market entry and adoption of AVT03 could enhance revenue diversification and growth prospects for Dr. Reddy’s, given the high cost and demand for Prolia® and Xgeva®.
Potential risks include regulatory hurdles and market competition from other biosimilars or new therapies. However, the established market presence and the cost advantage of biosimilars are positive factors.
This collaboration is particularly relevant in the context of the growing importance of biosimilars in global healthcare. Denosumab, the active ingredient in Prolia® and Xgeva®, addresses critical needs in osteoporosis and oncology, with biosimilars like AVT03 potentially offering cost savings without compromising efficacy or safety.
Alvotech’s role in developing and manufacturing AVT03 is crucial. Their expertise ensures the biosimilar meets stringent regulatory standards. Regulatory approval processes for biosimilars involve demonstrating biosimilarity to the reference product in terms of efficacy, safety and immunogenicity. Given the competitive landscape, AVT03 must meet these high standards to gain physician and patient acceptance.
This partnership enhances Dr. Reddy’s portfolio in regulated markets, reflecting confidence in Alvotech’s development capabilities. The anticipated regulatory and commercialization milestones suggest a structured approach to bringing AVT03 to market, which could expedite patient access to affordable treatments.
From a market perspective, this agreement underscores the increasing importance of biosimilars in reducing healthcare costs and expanding treatment access. The biosimilar market is projected to grow as patents for major biologic drugs expire, presenting opportunities for companies like Dr. Reddy’s and Alvotech.
Dr. Reddy’s exclusive commercialization rights in the U.S., along with semi-exclusive rights in Europe and the UK, position the company to capture significant market share. Their established distribution network and market presence are valuable assets in navigating the competitive biosimilar landscape.
The collaboration could disrupt the existing market dynamics for Prolia® and Xgeva®, challenging branded products with more affordable alternatives. This could lead to broader adoption of biosimilars in clinical practice, driven by cost savings for healthcare systems and patients.
For retail investors, the key takeaway is the potential for growth in the biosimilar sector, with Alvotech and Dr. Reddy’s poised to leverage this trend effectively. Monitoring regulatory developments and market penetration of AVT03 will be essential in assessing the long-term impact.
- Dr. Reddy’s gets exclusive commercialization rights in the United States (U.S.) as well as semi-exclusive rights in Europe and United Kingdom (UK)
- Alvotech will be responsible for development and manufacture of the product
HYDERABAD, India and REYKJAVIK, Iceland, May 21, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide (“Alvotech”), and Dr. Reddy’s Laboratories SA, wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd., (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY, along with its subsidiaries hereafter referred to as “Dr. Reddy’s”), today announced that the companies have entered into a license and supply agreement for the commercialization of AVT03, Alvotech’s biosimilar candidate to Prolia® and Xgeva® (denosumab). The collaboration combines Dr. Reddy’s global commercial presence with Alvotech’s proven capabilities in developing biosimilars for markets worldwide.
Prolia® and Xgeva® are indicated for the treatment of various diseases including osteoporosis in postmenopausal women and prevention of skeletal-related events in adults with advanced malignancies*.
Alvotech will be responsible for development and manufacturing of the product. Dr. Reddy’s will be responsible for registration and commercialization of the product in the applicable markets. The license and supply agreement includes an upfront payment to Alvotech, with additional payments upon certain regulatory and commercialization milestones as well as sales-based payments. Dr. Reddy’s commercialization rights are exclusive for the U.S., and semi-exclusive for Europe and the UK.
Erez Israeli, Chief Executive Officer of Dr. Reddy’s, said: “We are pleased to collaborate with Alvotech to make this denosumab biosimilar available to patients in the U.S., Europe and UK. Over the years, we have created a portfolio of biosimilar products, which are marketed in several emerging markets. Most recently, we launched bevacizumab, our first biosimilar in the UK. This strategic collaboration augments our growing portfolio of biosimilar offerings, and progresses our biosimilar journey further into the highly regulated markets. We look forward to leveraging our strong commercial capabilities in these markets to ensure patients receive access to best-in-class therapies and affordable treatment options.”
“We are proud to announce this new strategic partnership, that will enable us to increase the availability of cost-effective, critical biologic medications across multiple markets worldwide,” said Robert Wessman, Chairman and CEO of Alvotech. “Dr. Reddy’s shares our commitment to provide better access to safe and effective biologics. Biosimilars play an increasingly important role in global healthcare systems, offering broader access to best-in-class therapies. Combining our resources will ensure that patients globally can be better served.”
About AVT03*
AVT03 is a human monoclonal antibody and biosimilar candidate to Prolia® and Xgeva®, which are both denosumab but in different presentations. Prolia® is indicated for the treatment of osteoporosis in postmenopausal women and for bone loss in adult men and women at increased risk of fracture [1]. Xgeva® is indicated for prevention of skeletal-related events such as pathological fractures in adults with advanced malignancies involving bone [2]. In January 2024, Alvotech announced positive top-line results from a pharmacokinetic (PK) study which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult subjects [3]. A confirmatory efficacy and safety study for AVT03 in patients is currently underway, as well as a PK study comparing AVT03 to Xgeva® in healthy adult subjects. AVT03 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
*Does not include full list of indications, please refer to the PIs linked below for complete information.
References
- Amgen Inc. Prolia® (Denosumab): Prescribing Information. Available from: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Prolia/prolia_pi.pdf
- Amgen Inc. Xgeva® (Denosumab): Prescribing Information. Available from: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/xgeva/xgeva_pi.pdf
- AVT03 with Prolia in Healthy Male Subjects: Study Overview. Available from: https://clinicaltrials.gov/study/NCT05126784
Use of trademarks
Prolia® and Xgeva® are registered trademarks of Amgen Inc.
About Dr. Reddy’s Laboratories Ltd:
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil, and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance.
Over the last 25 years, our Biologics team has developed into a fully integrated organization with robust capabilities in the development, manufacture and commercialization of a range of biosimilar products in oncology and immunology. We have a current portfolio of six commercial products marketed in India, with some products marketed in more than 25 other countries. In addition, we have several products in the pipeline in oncology and auto-immune diseases in various stages of development for global launches across regulated as well as emerging markets. We are also ramping up manufacturing capacity to support our global expansion plans. In 2024, we launched our first biosimilar in the United Kingdom, Versavo® (biosimilar bevacizumab). This follows our launch of pegfilgrastim in the U.S and Europe through our partner. Our biosimilars business has a key role to play in driving both near-term and long-term growth.
For more information, log on to: www.drreddys.com.
DR. REDDY’S CONTACTS
| Usha Iyer Head of Corporate Communications ushaiyer@drreddys.com | Richa Periwal Head of Investor Relations richaperiwal@drreddys.com |
Dr. Reddy’s Disclaimer
This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words “may”, “will”, “should”, “expects”, “plans”, “intends”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, or “continue”, and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults, currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the “Risk Factors” and “Forward-Looking Statements” sections of our Annual Report on Form 20-F for the year ended March 31, 2023. The company assumes no obligation to update any information contained herein. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products.
About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline contains eight biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa, and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
For more information visit Alvotech’s investor portal, and website or follow Alvotech on social media on LinkedIn, Facebook, Instagram, X and YouTube.
ALVOTECH CONTACTS
Benedikt Stefansson
Senior Director of Investor Relations and Global Communications
alvotech.ir@alvotech.com
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FAQ
What is AVT03 that Alvotech and Dr. Reddy's are collaborating on?
What are the commercialization rights for AVT03 in the US, Europe, and the UK?
Who will handle the development and manufacturing of AVT03?
What kind of payments will Alvotech receive under this agreement?
What is the significance of Alvotech and Dr. Reddy's collaboration?
