‘Quiet Giant’ Biocon Sets Out Vision For Biosimilars

It has been a busy year for Biocon Biologics. After in September 2023 completing the North American integration of the front-end biosimilars business that it acquired from former partner Viatris in a $3.3bn deal (see sidebar), the company followed that up with a European completion shortly afterwards. (Also see "Taking Control Of Our Destiny: Biocon Biologics CEO Tambe Celebrates European Viatris Integration" - Generics Bulletin, 7 December, 2023.)

In the intervening months, the firm has ticked off achievements that include breaking $1bn in annual sales for the first time (Also see "Biocon Crosses $1bn Threshold In Biosimilars Revenue" - Generics Bulletin, 23 May, 2024.); negotiating a global settlement for its Stelara (ustekinumab) biosimilar (Also see "Biocon Expands Settlement For Stelara Rival To Cover Global Markets" - Generics Bulletin, 29 August, 2024.); and receiving the first approval for a rival to Eylea (aflibercept) in the US. (Also see "US Eylea Biosimilar Approvals Set Up Competition On Aflibercept" - Generics Bulletin, 21 May, 2024.)

And just recently, the company announced the successful pricing of Biocon Biologics’ debut $800m senior secured notes due 2029 – “the largest high yield debut USD bond issuance from India in the last 10 years” – and entered into a commitment agreement for a new syndicated debt facility, with the proceeds of the bonds and the debt facility being used “to substantially re-finance existing debt of $1.1bn.”

Shreehas Tambe, CEO and managing director of Biocon Biologics, said the move would fuel the firm’s long-term growth and was “core to the consolidation phase of our business.”

“We expect this transaction to strengthen our capital structure and allow us to re-deploy investments into the business, including advancing our differentiated pipeline of biosimilars,” Tambe set out. “It will also enable us to diversify our investor base to include marquee global funds and healthcare investors who seek to participate in Biocon Biologics’ growth story.”

With so much happening at Biocon Biologics, Generics Bulletin spoke to the firm’s chief commercial officer for advanced markets, Matt Erick – who has responsibility for North America, Europe, Japan, Australia and New Zealand – to discuss upcoming milestones and strategic priorities for the firm as it settles in for its second post-integration year.

Describing the firm as a “quiet giant” of a company, Erick speaks up about how the firm plans to grow in European markets that were previously not a priority for Viatris; how it is exploring in-licensing as well as in-house biosimilar development; how the firm is expecting the biosimilar Stelara market to shape up in the wake of its experiences with competition to Humira; and the latest on long-awaited US approvals for key products that have previously been held up by US Food and Drug Administration compliance issues.

North America Sees Fillip From Fulphila And Ogivri Growth

In North America, Erick said, “the business has grown remarkably well, particularly in the part B products, that would be your oncology products. We’ve seen quite significant favorability in our revenue and in market share” since taking over the business from Viatris, he observed, in particular pointing to “Ogivri (trastuzumab) and Fulphila (pegfilgrastim) growth of 10% over prior year in market share, and also increased revenue and increase in profit.”

Moreover, “we’ve seen our insulin glargine, which is our Semglee product, also grow. And when you look at the IQVIA data, there’s some things that aren’t reported – these closed networks – but we’ve enjoyed a closed network win that was not previous with the past owner. And we’ve grown our insulin glargine and continue to see nice progression with this, not only in the US but around the world.”

And in the competitive US market for biosimilar Humira (adalimumab), Erick said that Biocon Biologics was holding its own. “We do not have the high concentration [100mg/ml], we have the low concentration [50mg/ml],” he conceded, but “where we’re seeing Humira not on formulary, we’re doing quite well and being able to win the payer position but also pull it through at the physician level.”

“And then in Canada, we’re still seeing good positions with our insulin glargine as well as our Hulio (adalimumab) product, and we’re seeing progress and growth in our oncology products.”

“Where the previous owner was not focused, we’re focused there.”

Meanwhile, in Europe – where Biocon Biologics is “coming up in December on our first year anniversary” of integration – Erick said “we’re seeing the same thing: year-over-year growth from when we took this over, the whole portfolio. Hulio, our branded product, still remains the number one biosimilar in Germany and we’re also the top one in France.”

Touching on future prospects in the region, he said “what we’re leveraging now – as we look at progressing forward through the remainder of our first year anniversary and then on into next year – is how do we continue to grow in other markets within the big EU5 countries; where the previous owner was not focused, we’re focused there. And also how do we sell more of the products in our portfolio: insulin glargine, aspart; trastuzumab; and Hulio, that weren’t really the focus previously for the previous owner.”

Asked what was driving Biocon’s recent gains in biosimilars, Erick said “I think there’s a variety of things. Number one would be the sheer focus on biosimilars. We wake up each and every day, our whole salesforce, every one of the interdependent channels that we have that support the salesforce, focus on biosimilars – and I think that’s a key position there.”

The firm also benefited from its vertical integration, he suggested. “Now that we are what we like to call ‘from lab to patient’ – where we’re the R&D, the manufacturing and the commercial arm – it certainly gives us great insight to the marketplace as well as how we can compete versus some of the others that aren’t vertically integrated.”

Erick also suggested that Biocon’s “entrepreneur spirit” allowed the firm “to adapt quickly; where with some maybe larger companies it’s a little harder to turn that ship, we’re able to turn and refocus and redeploy much quicker because of our size and scale in our ability to flex.”

“Now that we have this commercial platform is now who can we partner with to in-license products to support the portfolio that we already have.”

In both Europe and North America, Erick said Biocon’s plan was to “continue to leverage the portfolio and leverage the success that we have. We’re focused on key therapeutic areas, our oncology portfolio, our diabetes portfolio and our immunology portfolio.”

“So it’s existing and then more products that we’re seeing coming down the launch pipeline, which some of those we have the opportunity waiting for approval – for bevacizumab, aspart in the US, denosumab, ustekinumab. So the portfolio is quite broad.”

Meanwhile, the firm would also look at partnerships and in-licensing to supplement its in-house developments, Erick suggested. “I think also what’s interesting for us, now that we have this commercial platform, is now who we can partner with to in-license products to support the portfolio that we already have, and be that commercial asset potentially for others, because we have this robust commercial engine now.”

‘Well Positioned’ To Harness Potential Of Ustekinumab

One major upcoming opportunity for Biocon Biologics is the loss of exclusivity for Stelara. The company has a settlement with the originator, Johnson & Johnson’s Janssen, that clears the way to launch its version of the top-selling $10bn+ immunology brand in the US, Europe, Canada and Japan.

“I believe we’re well positioned,” Erick said of the ustekinumab opportunity.

“We have, as you know, the settlement – we’re in that first wave (see sidebar). We have all the attributes, so we check all the boxes compared to the brand, whether it be patient assist programs, copay assist, the gauge of the needle, is it latex free, all those things that you see. So we’ve been able to check the box for payers as well as healthcare providers.”

“And then lastly, what I believe really distinguishes us is really the vertical integration. This product, we make; this product, we’re going to manufacture; and we’re going to sell.”

So “we’re well positioned for that,” he reiterated. And given that “we already have a salesforce in immunology, I think that will give us a lot of ability to be able to just add on and continue to grow. The doctors are familiar with us, with our relationships. And it fits nicely into our portfolio.”

Asked whether the approach on Stelara would be informed by experiences in the Humira biosimilar market so far, Erick confirmed that “the approach is the same. The approach is a [Medicare] Part D approach – you work with the payers, you work with the specialty pharmacies, and now, interestingly you work with these private labelers like Cordavis or Quallent, and we have all those relationships.” (Also see "Generics Bulletin Explains: US Adalimumab Outlook Brightens At Mid-Point Of 2024" - Generics Bulletin, 12 August, 2024.)

But “what makes it different, at least from our perspective, than adalimumab/Hulio, is really the attributes,” Erick suggested. “We have every one of those. As you know, with the Hulio adalimumab product, we had the low concentration and there were others that had [both] the high and the low. This one, we have no difference.”

“So I think we can leverage all of the positive things, being that vertically integrated company already having the integration, the relationships, and also now being able to have those relationships that we’ve already fostered with the physicians at the healthcare provider level.”

Talking of Humira, Erick was invited to comment on recent indications from Biocon Biologics that consolidation of adalimumab suppliers was expected in the US. (Also see "Biocon Expects US Adalimumab Market To Consolidate, Liraglutide Plans On Course" - Generics Bulletin, 19 August, 2024.)

“I think I’ll use a quote from the last time,” he reflected (see sidebar). “This is not a sprint, it’s a marathon. And I think you’re seeing that consolidation, and I’ll use it again, we’re in this as a marathon, and I think you’re going to continue to see these changes in the marketplace.”

“And I believe Biocon is well positioned because we are vertically integrated. We already have the commercial salesforce, we’re well established and also our portfolio is more broad. If you’re looking at just a couple of products, it could be tough, because you’re not going to win every single position; but if you have other products, you can weather the storms or you can celebrate successes and then continue to add additional products. So I think it’s very positive for us.”

Eylea Rival Slated For Launch In 2025

Another significant opportunity on the horizon for Biocon Biologics is its Yesafili (aflibercept) rival to the Eylea blockbuster ophthalmology brand, with Biocon having won trailblazing approvals in the US and Europe and looking to launch in Canada as early as June next year (see sidebar).

With the US and European approvals, Erick acknowledged that “we are the first, which is exciting. It’s always good to be first.”

And the product “fits nicely in Canada with our current portfolio. It fits nicely in the US with our current portfolio.”

“Clearly we have different timelines in Canada,” he noted. “In the US, it’s a little later in the timeframe“ – with the latest legal moves from originator Regeneron potentially delaying launch until 2027 (Also see ”Regeneron Blockade Leaves Biocon Facing 2027 Wait On US Eylea Biosimilar" - Generics Bulletin, 12 June, 2024.) – “but this product fits extremely nicely in the Part B programs, on how we look at going to market, how do you look at healthcare providers, managing your ASP [average sales price] pricing points and also working with the payers.”

However, Erick suggested, “with aflibercept, the challenge – and what we’re focusing on too – is giving the ophthalmologist more comfort and familiarity with biosimilars.”

“I think if you go back five to six years ago, oncologists had that feeling of ‘I’m not sure’,” he observed. “So our medical team and our medical folks are talking about biosimilars, and the success that biosimilars have, and the importance of the clinical efficacy around biosimilars and getting them more comfortable with biosimilars.”

“We can’t sell or talk about aflibercept really directly yet until we’re at that launch stage, but I think it puts very well with what we have already in both Canada and the US, and we’re ready with that timing. We’re hopeful that the courts will continue to evaluate and maybe see our perspective at a later date, for our launch, but we continue to remain very positive.”

Denosumab Is Uniquely Positioned In US Market

Asked about the denosumab rival to Prolia/Xgeva that Biocon has in development, Erick suggested that “this one is a unique product, since you have part of the product in Part B and part of the product in the Part D program. And so it has to be very strategic on how you go to market and how you are able to communicate to the healthcare providers, whether that be in the Part D or Part B program.”

“We will have both programs, meaning we both have the biosimilar to Xgeva and the biosimilar to Prolia. And so our approach is going to be what we’re good at. Our approach will be the one that is in Part B, the Xgeva, we’ll leverage our current platform; and the one in Part D, we’ll be bidding competitively where it makes sense for us, and then balancing how those two interact with each other, whether it be women’s health or oncology.”

“We’re looking forward to this soon,” Erick said of denousmab. “We haven’t balanced the exact pieces, but this is coming up and you can expect us to be in the pack as the biosimilars start to launch.”

‘Waiting Eagerly’ For FDA Action On Bevacizumab And Insulin Aspart

Erick also offered the latest on US biosimilars approvals that were being held up by a necessary FDA inspection – notably the firm’s bevacizumab and insulin aspart products, with the latter product still facing no biosimilar competition in the US.

“I can tell you this, that we have addressed what the [FDA] asked, and we call those the CAPAs [Corrective and Preventive Actions],” he set out.

“We’ve sent our CAPAs and responses back and we’re now waiting very eagerly and patiently for the FDA” to respond, Erick disclosed. “But we’ve submitted everything.”

“These are not for products that are already approved. It’s really for the bevacizumab of course – and then as you know, waiting on our final ustekinumab approval, which we anticipate could come next month or the month after that.”

A ‘Quiet Giant’ With A Global Outlook

Finally, asked to summarize the key milestones on the horizon for the company, Erick said “I believe Biocon is a quiet giant. And what I mean by that is that there’s a lot of successes.”

“As you know, prior we were the ‘Intel Inside’ or the engine inside of these products. And I think to me, the up and coming piece is that the industry is going to see Biocon Biologics continue to launch products, continue to be that manufacturer of choice, and you’re going to see us continue to leverage all markets, whether that be in North America, whether that be in Europe, or the emerging markets.”

“We are a global company that just happens to have manufacturing in India, but we are pretty much selling in just about every country now. And so when we look at this perspective, we see this as a global marketplace for us. Clearly there’s a certain importance in different markets, but we look at this globally, not just in one country at one time.”

Ultimately, he said, “I think the more we can have dialogue and get out the message, I think the more people will understand what we have to offer. And it is quite significant. When people really study Biocon Biologics and Biocon, they kind of go, ‘wow, I didn’t know’. And I think that’s our strength.”