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Broadening Access to Biologic Medicines DIGITAL REPORT 2022

IN ASSOCIATION WITH:

alvotech.com

ALVOTECH

BROADENING

ACCESS TO

BIOLOGIC

MEDICINES

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ALVOTECH

From insulin to vaccines and cancer therapies, biologic medicines have a huge impact on healthcare, and it’s Alvotech’s mission to make such medicines more affordable and more widely available

ost businesses have a mission, but not all missions are equal. Alvotech’s mission is to improve patient lives through broadened access to biosimilars. The company was founded in Iceland in 2013 and it employs an integrated business model, from research and development (R&D) through production. Alvotech is fully integrated and fully focused on biosimilars. For the non-biochemists among us, let’s turn to an expert to learn what a biosimilar is: Gerhard Helmerich, Head of Global Supply Chain at Alvotech. “To understand biosimilars you first have to understand biologic medicines. These are generally large, complex molecules that are produced through biotechnology in a living system, such as a microorganism, plant or animal cell.” These medicines differ from smallmolecule drugs, which are chemically synthesised. Examples of small molecule drugs include typical ‘medicine cabinet’ treatments, such as aspirin and paracetamol. “Biosimilars are more difficult to characterise than small molecule drugs,” says Helmerich, “because of inherent variations present in biological products.” This natural variation is why it is not possible to create an exact copy, or a generic version, of a biologic, as is the case for smallmolecule drugs. But what can be created is a highly similar version of a licensed biologic

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Broadening access to biologic medicines that save

with no clinically meaningful differences in terms of safety and effectiveness from the reference product. Biosimilar drugs have a pivotal role to play in public health, as they offer additional treatment options that are typically more affordable than their branded counterparts. This is positive news for key therapeutic areas such as autoimmune diseases and cancer, which already have approved biosimilars on the market. Little wonder, then, that the global biosimilar market was valued at US$30bn in 2020, and that it is expected to grow to approximately US$80bn over the next six years. It’s one thing for Alvotech to aim to improve patient lives through broadened access to biosimilars, but how exactly can the company achieve this? “By making sound, strategic decisions,” explains Helmerich. One such decision includes Alvotech’s commercial strategy. Early in its life, Alvotech was debating if it should seek a global partner or go with ‘local champions’. 6

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“Ultimately, we chose a local approach,” says Helmerich. “Since that decision was made, we have partnered with top firms who are leaders in their markets. Being able to rely on the scale and expertise of our partners allows us to focus on what we do best development and manufacturing.” Another important decision is Alvotech’s differentiated portfolio. “Each market is

GERHARD HELMERICH TITLE: HEAD OF GLOBAL SUPPLY CHAIN INDUSTRY: BIOSIMILAR MEDICINES LOCATION: ICELAND

unique and requires a different approach,” says Helmerich. “We believe a company can differentiate through its portfolio strategy.” The third strategy has been to fully integrate, from R&D to manufacturing. To date, large pharmaceutical companies have dominated the biosimilar space in part because of their scale and capital. Alvotech is fully committed to biosimilars and has

EXECUTIVE BIO

Gerhard Helmerich is an accomplished supply chain executive with over 17 years of experience in the pharmaceutical industry directing global, crossfunctional teams, leading complex projects, and delivering high impact initiatives across commercial supply chain and various technical development functions. At Alvotech, Gerhard Helmerich leads Global Supply Chain, overseeing supply logistics for multiple commercial and development products. His mandate also includes site operations, warehouse activities, procurement of materials and devices, external supply operations, integrated business planning and life cycle management activities. Gerhard Helmerich holds a PhD in Chemistry from the Technical University in Munich, Germany.

Make the move to networked manufacturing Make theandmove toglobal Access a reliable harmonized supply chain for single-use products networked manufacturing With the continued adoption of single-use technologies, specifically in cGMP

Accessconsistent a reliable global manufacturing, product supply and and qualityharmonized are very important. Our global network of single-use manufacturing sites has expanded and is supply chain for single-use harmonized to provide equivalent processes and procedures that products produce products of consistent quality, form, fit, and function. With the continued adoption ofabout single-use technologies, specifically in cGMP Reach out to us today to learn the value of multisite qualification to manufacturing, consistent product supply and quality are very important. take advantage of the benefits of networked manufacturing. Our global network of single-use manufacturing sites has expanded and is harmonized to provide equivalent processes and procedures that produce products of consistent quality, form, fit, and function.

more ReachLearn out to us todayat to thermofisher.com/flexiblecontainment learn about the value of multisite qualification to take advantage of the benefits of networked manufacturing.

Learn more at thermofisher.com/flexiblecontainment

For Research Use or Further Manufacturing. Not for diagnostic use or direct administration into humans or animals. © 2021 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. EXT1755 1121

Thermo Fisher: Supplying a Healthier, Cleaner, Safer World Thermo Fisher has transformed its supply chain to emerge more agile, resilient and collaborative from a period of acute industrywide disruption With a mission to “make the world healthier, cleaner and safer”, Thermo Fisher is a key supplier to the life sciences industry and a close collaborator with the field’s leading organisations. Christine Callahan, Vice President of Global Supply Chain, Life Science Solutions, who joined Thermo Fisher amid the early waves of COVID-19, is spearheading a transformation of the firm’s supply chain. “We are moving away from PO-based and transactional relationships to true partnerships, true collaboration with more transparency,” says Callahan. Pharmaceutical innovator Alvotech is a key customer and close partner that epitomises this new mindset for Thermo Fisher, says Callahan: “Alvotech is a very key customer and partner for us, and we want to continue to earn their business and grow with them as they grow.” During the turbulence caused not just by COVID-19, but by extreme weather and geopolitical uncertainty, “there have been some real challenges,” Callahan adds. “It has not been simple and straightforward, so we’ve been working extremely collaboratively with Alvotech.

I’m really proud of our teams’ commitment to them, and our urgency with solving their problems,” she says. “And given that they’re such a great partner, innovating and collaborating with someone so receptive and supportive helps the overall synergy in the solution.” Lessons learned and innovation borne out of the pandemic have galvanised a more resilient and agile Thermo Fisher. It is an organisation that has been strengthened by solving problems during this period of acute demand, and which will emerge stronger for it. Callahan says it has been the “silver lining” of the past two years. Thermo Fisher will continue to innovate to meet the growing demands of its partners. “We’re undergoing a real paradigm shift in the thinking, and we’ve always been conscious of supply chain continuity and resiliency,” Callahan says. “In this space, you have to be caring about that in a growth environment, but most importantly, our end customers are patients and we need to be there for them. We can’t ever let our customers down.”

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invested in a scale that it believes will be necessary for the next ten years of its life cycle. These three strategies give Alvotech the focus, scale and speed needed to achieve its mission. It’s been quite a journey for Alvotech since it was founded in Reykjavik, Iceland by current Chairman, Róbert Wessman. Alvotech isn’t alone in its journey; Helmerich, too, has had an eventful and varied career. He first studied food chemistry at the Technical University of Munich, later also completing a PhD in chemistry there. “I have been overseeing the global supply chain at Alvotech for almost a year now,” says Helmerich. “I am responsible for supply logistics across multiple commercial and development products including site operations, warehouse activities, procurement, external supply operations, integrated business planning and life cycle management activities.” Beyond Alvotech, he has 17 years of experience in the pharmaceutical industry, most recently at Novartis Pharma in Basel, Switzerland. Although Alvotech is based in Iceland, Helmerich himself is in Zürich, and travels frequently to the company’s headquarters in Reykjavik. “I enjoy it every time I go there,” he says. “It’s a beautiful country with wonderful people.” Helmerich says that in the year he has been with Alvotech he’s witnessed “great leadership, energised teams and the passion of an entire organisation working towards the same mission”. “I could feel how proud people are to work for Alvotech from day one,” he adds, continuing: “We are passionate people, working to bring more affordable and accessible biologic medicines to patients around the world, and this purpose drives our daily work. We have a strong 10

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ALVOTECH Alvotech has its HQ in Reykjavik, Iceland, a location that plays a key part in the company’s sustainability strategy, says Gerhard Helmerich, Head of Global Supply Chain at Alvotech. “Environmental footprint is very important to us and being in Iceland means we have access to sustainable energy resources. Nearly all the energy produced in Iceland comes from renewable sources, either hydro, geothermal or wind.” There are other benefits to being based in Iceland. The company’s founder, Róbert Wessman, is Icelandic, and he recognized the potential for locating a biopharmaceutical in his homeland.Iceland has a flourishing biotech industry and a strong talent pool of pharmaceutical specialists. The facility is based in the University Science Park in Reykjavik, and there is close collaboration with the University of Iceland. “Iceland is the cornerstone in our path to success,” says Gerhard Helmerich. “Being here helps attract talent to the company.” It also helps that Iceland is right in the middle of global time zones, making it easier for Alvotech’s multinational team and partners to communicate.

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“ Iceland is the cornerstone in our path to success,” says Gerhard Helmerich. Being here helps attract talent to the company” GERHARD HELMERICH

HEAD OF GLOBAL SUPPLY CHAIN, ALVOTECH

emphasis on excellence, collaboration and ingenuity.” Helmerich says he’s also been impressed by how progressive and diverse Alvotech is. “We work in a very diverse environment. It’s been great seeing how inclusive the culture is. These characteristics will get us through any challenging times. I strongly believe diversity generates stronger strategy and better risk management, debates and outcomes.”

It may have been a rewarding ten months for Helmerich, but it’s also been turbulent, as it has for most businesses in biotech and beyond. “We’ve faced supply chain problems, just as every other pharmaceutical company has,” says Helmerich. “Manufacturing and distribution are perhaps the most obvious problems of the past two years, and most disruptions on materials and consumables have come with short notice.” He adds: “Although the past two years have not been easy, we’ve taken this as an opportunity to rethink our ways of working and to increase our supply chain resilience. Unexpected delivery shortages gave us a clear view on the areas we needed to focus on.” Helmerich believes all problems end up being resolved in the same way - by people. “Everything always comes down to people alvotech.com

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“ We have a strong supplier network and are ready and excited to transition to the commercial phase.” GERHARD HELMERICH

HEAD OF GLOBAL SUPPLY CHAIN, ALVOTECH

in the end. We got through it because our people worked together to find the best way of collaborating with suppliers.” Among its suppliers are Thermo Fisher, Purolite and Asahi Kasei Bioprocess. “They have been supporting us since the start of our journey and are key suppliers to Alvotech,” says Helmerich. “Thermo Fisher supplies a variety of different materials and equipment, Purolite is one of our resin

suppliers and Asahi Kasei delivers different kinds of filters.” “We are very thankful to have them on board, supporting our mission. All our partners go the extra mile to address the needs we have. They think out of the box, are very proactive and focused on continuous improvement.” As well as supportive suppliers, Helmerich says he has an outstanding supply chain team, “eager to solve problems and meet challenges”. “I can say we are grateful for the pandemic experience because it’s allowed us to strengthen our relationships with many key partners, who of course have also been facing their own challenges. Extraordinary commitment and support from both sides is what made the difference.” Although Alvotech has biosimilar candidates under development and regulatory review, so far it has none on the market. So, is its supply chain ready to swing into action when needed? “Absolutely,” says Helmerich. “Throughout 2021 we finalised the blueprint for our supply chain organisation. We have a strong supplier network and are ready and excited to transition to the commercial phase.” The company’s product pipeline contains several biosimilars aimed at treating a mix of autoimmune, oncology and inflammatory conditions. The most advanced asset in its pipeline is AVT02 - a proposed biosimilar for high-concentration adalimumab. Adalimumab is an anti-TNF drug that is sold under the brand name Humira®. In November 2021, AVT02 was approved by the European Medicines Agency. The company’s other disclosed biosimilar candidates include additional targets in immunology, ophthalmology, oncology and bone disease, specifically Stelara® (ustekinumab) and Simponi®/Simponi alvotech.com

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“ I believe diversity generates stronger strategy and better risk management, debates, and outcomes” GERHARD HELMERICH

HEAD OF GLOBAL SUPPLY CHAIN, ALVOTECH

ARIA® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). “We have commercialisation agreements with multiple regional partners and have plans to market our biosimilars in at least 90 countries,” says Helmerich. So, what about the future? Where will the company be in five years’ time? “Our vision is to build a leading global biopharmaceutical company,” says Helmerich. “By then we will hopefully have multiple products on the market through our partnerships and will be closer to bringing a robust pipeline of affordable biosimilars to patients around the world.” Helmerich says Alvotech will continue to pursue its diverse pipeline of biosimilar programmes. “Our integrated platform and network of world-class partners will allow us to reach patients with more affordable biosimilars, while positively impacting the global healthcare ecosystem.” He says that when the company succeeds in increasing access to these important biologic medicines for patients “then all our efforts will have been worth it”.

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