Pierluigi Antonelli was less than three months into his role as a member of the Management Board of Fresenius, responsible for the group’s operating company Fresenius Kabi, when he recognised an eye-catching ambition for the firm: to treble or even quadruple by 2026 Fresenius Kabi’s 2022 Biopharma business unit sales of around €200m ($206m), while “significantly improving margins,” as a result of the company’s already well-established ‘Vision 2026’ strategic roadmap.
Fresenius’ investments in biosimilars, not least its €495m acquisition of a 55% stake in mAbxience in 2022 by Fresenius CEO Michael Sen, and subsequent regulatory progress since that May 2023 capital markets day, have left Fresenius Kabi – shortly after Antonelli’s 1 March two-year anniversary at Fresenius Kabi – “on the right track,” he tells Generics Bulletin in an exclusive interview.
In February the company communicated a new medium-term ambition for Biopharma to achieve revenues of more than €1bn and being accretive to Fresenius Kabi’s structural margin band of 16% to 18%.
Bringing more than 20 years of pharma experience to his position at Fresenius Kabi, Antonelli held senior European roles with several major players on both sides of the pharma aisle, including Bristol Myers Squibb, Merck & Co and – between 2015 and 2018 – Sandoz, where he was the leader of its business in Western Europe.
Following a brief stint at Novartis as head of oncology in Europe, Antonelli took up his first CEO role in March 2019 with Angelini Pharma, part of the privately owned Angelini Holding.
“On top of the experiences with multinational companies, it was my experience with a family-owned company – one that has been in business for over a hundred years – which was also very transformational. It helped me to quickly land at Fresenius Kabi, with its broad portfolio covering IV drugs, including IV and irrigation solutions, as well as the three growth vectors: Biopharma, Clinical Nutrition, and MedTech,” Antonelli tells Generics Bulletin, talking from Fresenius Kabi’s headquarters in Bad Homburg, located to the northwest of Germany’s financial hub, Frankfurt.
In the two years since taking up the mantle at Fresenius Kabi, Antonelli says he is most proud of his team and their joint efforts to deliver on those ambitious goals outlined at the start of his tenure.
“When back in May 2023 Fresenius CEO Michael Sen and I shared our common goals for our already introduced Vision 2026 strategy, I got a couple of analysts who were challenging me on our ability to make those statements,” Antonelli points out.
“And my answer was: ‘Look, at that time, I was three months in the company. But you will see, we think that we are serious about our commitment.’”
As Antonelli points out, “since the first quarter of 2023, we’ve been able to hit or even surpass our commitments contributing to the overall performance of Fresenius. So, we want to continue regaining trust in the marketplace, from our shareholders in line with the overall strategic pathway ‘#FutureFresenius’. And I think we have solid plans to continue to be on the right track for the future.”
The team has changed since Antonelli’s appointment. In came Sang-Jin Pak, previously executive vice-president of the global commercial business at Samsung Bioepis, as head of Fresenius Kabi’s Biopharma business, taking over from Michael Schönhofen in June last year.
Meanwhile, the former Dr Reddy’s, Sandoz and Torrent executive Arunesh Verma now oversees Fresenius Kabi USA, replacing in July last year the long-serving John Ducker, who retired after a highly successful 35-year career with the firm.
“Having the right team makes a big difference,” Antonelli says, “strengthening the quality of the team and moving forward in terms of the operational excellence and execution which are extremely important.”
Overall, Fresenius Kabi’s CEO says he feels “comfortable and confident that we have a team that can continue the great momentum we are having.”
“But there is much more to come beyond 2026, also within the Biopharma business, and that will remain a growth driver for us in the foreseeable future.”
‘Fundamental Piece Of The Puzzle’
In 2024, Fresenius Kabi’s Biopharma sales climbed by an organic 76% to €611 million, primarily driven by the overall good rollout of the firm’s Tyenne (tocilizumab) biosimilar to Actemra/RoActemra in Europe and the U.S.
In particular, “our majority stake in mAbxience has been a fundamental piece in this puzzle because it allows us to jointly cover the entire value chain,” Antonelli says.
“We provide the commercialization platform. mAbxience is extremely strong on their production platform, on drug substance. Also,” Antonelli continues, “our portfolios are extremely synergistic: mAbxience more on oncology; ours more on the autoimmune side. So, when you pull the two together, I believe we have a very strong foundation platform that will be competitive for the long term.”
The Spanish-based developer is also helping to push Fresenius Kabi in a new – and potentially lucrative – direction, striking two global licensing agreements in the space of six months with Teva, including one for an undisclosed anti PD-1 oncology biosimilar.
“Teva is a reputable player in that space, and we believe that, based on their commercial capabilities, they’ll be able to exploit the assets and create adequate value for them,” Antonelli commented.
With the proposed Teva-partnership launches set to materialize towards the end of this decade, Antonelli notes: “In pharma you have to be able to think short- but also long-term and always be able to maintain that balance.”
With that in mind, Fresenius Kabi just recently struck a licensing agreement with South Korea’s SamChunDang Pharm, giving it exclusive commercialization rights in the US to the firm’s aflibercept biosimilar candidate in the US, as well as several countries in Latin America.
Tocilizumab Continues With ‘Great Momentum’
As Antonelli notes, Fresenius Kabi’s tocilizumab biosimilar has launched well in Europe. It has reached a share of around 22% in the top five EU markets in December 2024, a feat made possible by Fresenius Kabi offering a variety of presentations for the molecule and by moving first on the opportunity.
By opening up competition, he sets out, “we’ve been able, with appropriate large preparation, to hit the ground very fast and have been able to meet successfully with payers across the board. We have pretty much the whole of Europe covered, on top of some other countries outside of Europe; and of course the US.”
In the world’s largest pharma market, Fresenius Kabi has been “quite pleased with the evolution of Tyenne,” despite the complex pricing and reimbursement environment, Antonelli says. Fresenius Kabi, he notes, is now supplying Tyenne to more than 100 payer agreements, “that is very encouraging and a great step forward into making healthcare more affordable in the US.”
“We also see that in many of those accounts we are moving into exclusive positioning from 2025, which we find gives us the opportunity to grow and have Tyenne becoming a very important asset in our portfolio.”
In summary, he says of Tyenne: “It continues with great momentum, picking up month by month. We expect an increasing contribution from the US this year.”
Moreover, the US market dynamics had made the launch of Tyenne “a different story” to that of Idacio, the firm’s biosimilar to Humira that launched as part of the ‘second wave’ of adalimumab biosimilars in the middle of 2023.
With Fresenius Kabi having just launched its Otulfi biosimilar to J&J’s autoimmune diseases blockbuster Stelara (ustekinumab), I ask Antonelli what lessons he and the firm has learned from the Sisyphean task of jostling for space with payers and providers for adalimumab. And was he expecting a similar uphill battle this time around for ustekinumab?
“We treasure the learnings that we had with the launch of Idacio in the States and we are applying our knowledge and the expertise that we gained [to Otulfi],” Antonelli comments.
While acknowledging that, yes, it would again be a competitive market with a host of biosimilar players targeting the opportunity, the sheer size of Stelara’s brand and the lessons learned “gives the opportunity honestly to have a cut of it.”
“We are more and more completing our portfolio when it comes to immunology,” Antonelli points out, “and therefore payer and physicians will have multiple choices at their disposal to use the right biosimilar in treating the right patients, while still having the opportunity for other patients to continue to use innovative brands.”
“So, honestly, there is appropriate space for all the different players, and this is something that I think drives also our investment choices moving forward in terms of building up our pipeline in the future.”
$1bn Investment In Manufacturing
Away from biosimilars, Fresenius Kabi remains, of course, one of the world’s leading suppliers of generic intravenous drugs in anesthetics, oncology, anti-infectives, and critical care and fluids, and launched the first US generic version of epinephrine in a 1mg/1ml vial in December 2024.
Antonelli paints the company’s core IV drugs portfolio and pipeline as the hull of Fresenius Kabi’s ship, the rock-solid foundation “where we are system critical to healthcare systems around the world,” a business that churns out dozens of launches: 10 in 2024 in the US alone, and significantly more to come over the next two years.
“In the US, 70% of the molecules in our portfolio are in the FDA Essential Medicines list and we therefore want to continue to have a pipeline there, including more differentiated products that can allow us to maintain that level of profitability and fend off the classic competitive downward pricing spiral that exists everywhere, but especially in the US,” Antonelli says.
One of these, buried within the firm’s pipeline, is a GLP-1 asset, the current darling of the industry. “We assess opportunities to potentially strengthen that part of the portfolio moving forward,” Antonelli reveals.
Fundamentally, the company’s main investments will include 505(b)(2) hybrid new drug applications, “a classic thing,” Antonelli says, and different avenues for products such as branded generics or agreements with companies “on managed entry” for off-patent drugs.
“But this is one of the fields where we will continue to invest moving forward,” he reiterates, “to ensure we can, while remaining fundamental in the eyes of payers, drive even incremental value out of it.”
Powering Fresenius Kabi’s aspirations is its string of pharmaceutical production facilities, in which the firm has invested more than $1bn in recent years. Three of these – Wilson, Grand Island and Melrose Park – are located in the US, producing vital drugs for distribution across the country.
“Supply chain does play a significant role in terms of stability and solidity,” Antonelli says, with Fresenius Kabi’s credentials recognized by several awards including the 2024 Trailblazer Award from Premier’s group purchasing organization category.
“So, our significant investments are paying off and will continue to pay off moving forward,” Antonelli feels, “because we assure high quality products with a very solid supply chain reliability, which these days is fundamental, especially with shortages.”
With Fresenius Kabi having previously outlined its ability to “be there for patients and to do everything in our power to counteract shortages,” Antonelli notes that the firm will continue to push in this direction, as it did last year following Baxter’s North Cove manufacturing site being significantly impacted by the rain and storm surge from Hurricane Helene.
“If you’re thinking about IV solutions, the IV fluids following the hurricane Helene issue, we are finding ways to accelerate our ramp-up volume in Wilson in order to help. After all, IV solutions are system-relevant products for healthcare provision.”
And in broader terms, Antonelli acknowledges that the company’s recent successes – in Biopharma, in generics, and beyond – can be credited to Fresenius Kabi’s staff. “People are the ones who, at the end of the day, make the successful translation of strategy into reality possible or impossible.”
