Celltrion Executive Discusses Adalimumab Biosimilar Candidate

The Center for Biosimilars® (CfB): I’m Tony Hagen, Senior Editor for The Center for Biosimilars®. Today, we’re talking with HoUng Kim, PhD, head of the Medical and Marketing Division at Celltrion Healthcare. We’re discussing CT-P17, the company’s citrate-free, high concentration adalimumab biosimilar, which has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use [CHMP].

Please tell us about the citrate-free, high-concentration formulation of adalimumab that Celltrion is developing and why this is important for patients and providers.

Kim: The high-concentration formulation enables low volume and, along with being citrate-free, it leads to reduced pain, which will contribute to improved treatment adherence, which is important for chronic diseases that require long-term management.

In terms of the [administration] device, it includes a proper needle size (29G), it is latex-free, which can reduce allergy risk, and the product has a long storage period or shelf life at room temperature (30 days), all of which will contribute to improved convenience for patients as well as providers.

CfB: You recently announced a CHMP positive recommendation for CT-P17. Have you applied for approval also in the United States? Also, you’re seeking approval for all indications of the originator product, is that right?

Kim: We submitted the dossier to the US FDA last November and we are aiming to have full indications approved. We hope this will improve access to high-concentration, low-volume, and less-painful adalimumab.

CfB: Assuming you receive European Commission [EC] approval, when would you be able to launch in Europe, and which countries would you start in?

Kim: Right after EC approval, we will initiate the pricing and reimbursement [P&R] process. The duration will depend upon each national process and their system, which varies country by country, but we’ll initiate the process right after the EC approval. Considering biosimilar precedents, we assume that this will take place faster than new drug applications. We aim to expedite the process in the EU5 [European Union 5 includes France, Germany, Italy, Spain, United Kingdom] especially.

CfB: Are there any AbbVie patents or exclusivities in Europe that would delay the immediate launch of this product?

Kim: We have completed the discussion on patent settlements in the United States and are approaching settlements in Europe. That’s all that I can disclose at this time.

CfB: Why did you decide not to bring a lower-concentration version of adalimumab to market?

Kim: With high concentration, low volume, and consequently less pain, adalimumab can improve treatment adherence at the very least. Therefore, we thought a high-concentration version has the potential to dominate the adalimumab category as long as we maintain parity in the price range compared with low concentration versions.

CfB: Can you tell us about the trend in the market for adalimumab sales and why the high-concentration form might be better positioned for gaining market share than the lower-concentration versions?

Kim: We reviewed the IQVIA data, and already the majority of adalimumab use has been transferred to the high-concentration version, and patients have talked about the virtue of a high-concentration or low-volume and less-painful version of adalimumab. So, we can utilize this precedent that has been established in the market.

CfB: What is the market share for the high-concentration version?

Kim: In Europe it’s around 60% and in the United States around 70%; and the originator company AbbVie has replaced low to high, so the proportion of high concentration in Europe is already over 90%.

CfB: CT-P17 would potentially be the first high-concentration, citrate-free adalimumab biosimilar available in Europe, is that right?

Kim: There are several citrate-free adalimumabs. However, CT-P17 is the first that is also a high-concentration and low-volume adalimumab biosimilar candidate.

CfB: How would this be an advantage in pricing and market access for CT-P17? Can you share your anticipated discount from high concentration originator adalimumab? (in Europe)

Kim: Our price will be similar to the biosimilar versions of adalimumab and not the originator—that’s our P&R strategy. So, we anticipate that high concentration and low volume will be an advantage in pricing and market access, as long as we maintain a similar price range compared to the low concentration versions of adalimumab biosimilars.

CfB: AbbVie has also introduced such products as Rinvoq and Skyrizi. How much of the adalimumab market might these eventually take over, or do you feel that they do not strongly differentiate from adalimumab?

Kim: Considering the nature of the disease is a chronic one, which requires long-term treatment, there’s no single medication that can control this type of condition lifelong, so there is a need for several drug options during the treatment period. The initial thought is that there will be some proportion that will be maintained for the adalimumab market. With regard to the new entities, safety signals such as thromboembolism were not initially detected, but now these have been added as warnings on the label of JAK inhibitors.

CfB: How important is CT-P17 to your overall biosimilar marketing plan?

Kim: Adalimumab is the best-selling medication in the world. Now, we have access to this market, which will bring us another opportunity for growth.

We have another TNF-alpha blocker, which is infliximab, but these products have a different preference in terms of segments. Sometimes they can be used sequentially to bring clinical benefit for chronic diseases that require long-term treatment. So, we assume that CT-P17 will contribute to helping us consolidate a leadership position in the biosimilar category.