The Center for Biosimilars spoke with Byoungseo Choi, head of marketing for Celltrion Healthcare, a company very active in the biosimilar space.
In part 1 of this interview, Choi discussed Celltrion’s infliximab biosimilar (Inflectra, Remsima) and how it may aid in the treatment of coronavirus disease 2019 (COVID-19)–related inflammation. Choi also talked about the company’s ambitious plans to launch 1 new biosimilar each year through 2030.
In part 2 of this interview, Choi continues the discussion with Center for Biosimilars® Senior Editor Tony Hagen about the company’s biosimilar pipeline, the competitive landscape for Celltrion’s products, especially adalimumab, and the company’s plans to build a biosimilar production center in Wuhan, China.
Below is a list of the questions that were provided to Celltrion in advance of the interview, along with Choi’s responses.
What’s in the near-term pipeline to accomplish Celltrion’s anticipated approval filings and launches in the United States and Europe?
Following the EU marketing authorization for Remsima SC for the treatment of people with rheumatoid arthritis issued in November 2019, the Committee for Medicinal Products for Human Use (CHMP) of the EMA has recommended expanding the existing marketing authorization in an additional five indications: for the treatment of people with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis. Generally, the EC gives final approval within three months after the CHMP’s opinion. In the US, Celltrion plans to go through a new drug pathway in order to receive US Food and Drug Administration (FDA) approval by 2022.
Celltrion has applied for the European Medicine Agency’s commercialization approval of CT-P17, a Humira (adalimumab) biosimilar in March this year. We plan to launch CT-P17 in the EU market once authorization is granted from the EMA next year. We have submitted clinical data based on all indication approved for Humira, including rheumatoid arthritis, ulcerative colitis, and psoriasis.
CT-P17 will be the first high-concentration type of medicine for a biosimilar made of adalimumab. CT-P17 could be more convenient for patients by potentially reducing the injection volume. The drug is citrate-free, meaning it causes less pain upon injection.
Celltrion carried out phase 3 clinical trial of Genetech’s Avastin (bevacizumab) biosimilar CT-P16 for metastatic colorectal cancer, metastatic breast cancer and non-small cell lung cancer indications and completed recruitment of patients. Celltrion successfully completed Phase 1 clinical study on the safety and pharmacokinetic assessment of CT-P16 in June 2018. Beginning with Portugal, Celltrion is set to conduct Phase 3 clinical trial for CT-P16 in about 150 sites in some 20 nations across Europe, Asia and South America. Celltrion plans to apply for European submission next year.
Celltrion also plans to develop Novartis’ asthma and rash treatment Xolair (omalizumab) biosimilar, CT-P39. Celltrion is carrying out phase 1 & 3 clinical trial of the CT-P39 and anticipated to complete the trial by 2022.
Product differentiation has been an important way Celltrion has chosen to gain an edge in the marketplace. The high concentration formulation of CT-P17 is an example. What’s the market for this in Europe and how does Celltrion expect this formulation to perform?
CT-P17 is a high concentration formulation of adalimumab and could be a more convenient option for patients by potentially reducing the injection volume. CT-P17 will be a citrate-free formulation, which can reduce the pain of the injection. Celltrion plans to optimize method of administration and regimen by offering various strengths. In terms of portfolio strategy, CT-P17 can be used as sequential treatment with CT-P13 SC so that patients can use a drug in terms of achieving long-term drug survival.
Please could you comment about the competition Celltrion faces from AbbVie, which has sought to leapfrog adalimumab biosimilars with follow-on products such as Skyrizi.
It’s no doubt that Abbvie is trying to strengthen its products’ competitiveness by adopting different strategies. We plan to closely monitor the current dynamics of the market, including the new entrant strategies and market penetration strategies of our competitors.
Is Celltrion seeking to bring CT-P17 to market in the US and does it have an application in with the FDA?
Celltrion plans to submit an application to the US FDA, as the patents for Humira will expire in 2023 in the United States.
In 2023 in the United States, Humira faces possible competition from at least 5 biosimilars from 5 makers: Amgen, Amgevita; Merck, Hadlima; Boehringer Ingelheim, Cyltezo; Sandoz, Hyrimoz; and Pfizer, Abrilada.
Remsima SC is also a form of product differentiation. Please could you talk about your strategy with this product. You have already been very successful in Europe with just this infliximab product.
Infliximab is an IV anti-TNFα therapy, in which its safety and efficacy are supported by nearly 20 years of real-world experience.
Infliximab has well-established clinical profiles for the treatment of autoimmune indications such as rheumatoid arthritis whilst it is proven to be comparatively effective in treating IBD compared to other biologics (ref: PANTS study) and for its rapid onset of response, there has been a need of improved convenience feature to its formulation.
Celltrion expects that Remsima SC will be the first and only subcutaneous infliximab to be available in Europe offering patients who are starting or switching anti-TNFα therapy with the proven benefits of infliximab in a more convenient form.
Remsima SC will offer stable potency and low immunogenicity compared to the IV formulation as well as increased flexibility and convenience through self- administration.
Also, physicians will have more flexibility or more tailored approach when it comes to deciding whether a patient should receive Remsima IV or SC according to each individual patient’s condition or disease state. For instance, an IV formulation could be used to induce a rapid response in patients whilst SC can be utilized to maintain a better drug survival rate. This flexibility allows physicians to make the optimal choice for their patients.
Please could you say a few words about the difference in your development plan between biosimilars and bioinnovatives and explain how these fit into your strategy.
The posology and route of administration of CT-P13 SC is different from CT-P13 IV (Remsima), so Celltrion has filed its application to the EMA as an extension application. Therefore, the concept of bioinnovative applies to CT-P13 SC in Europe; however, in the United States, Celltrion plans to go through a new drug pathway.
Celltrion believes the regulatory environment is accommodating innovation in biosimilars and that regulations relating to biosimilars should promote innovative research into high quality new medicines.
If approved CT-P13 SC would be the world’s first subcutaneous version of infliximab, expanding treatment options for physicians and patients.
Please could you update us on the Wuhan factory development plan. What’s the situation over there now with the relaxation of COVID-19 restrictions, and has Celltrion been able to move forward with construction or construction planning?
The Wuhan project is still on hold due to the COVID-19 pandemic. It is difficult to say how the ongoing outbreak will affect our plans at this moment. We are closely monitoring the situation and will continue to communicate with the officials of Hubei province.
Why situate the factory in China? Is there a long-term goal to serve that market, or is it the labor supply, or both?
Celltrion planned to build a facility in Wuhan targeting the Chinese domestic market including research and development (R&D), contract manufacture organization, and production in the longer term.
Are there other developments that Celltrion would like to mention?
Celltrion plans to develop high quality biosimilars for various biologics. We plan to launch either a monoclonal antibody biosimilar or new drug every year to enrich our product pipeline. These will include biosimilars, bioinnovatives (ie, value-added medicines), and new drugs.
We have also signed an agreement to acquire product assets for the Asia Pacific region from Takeda in an effort to strengthen its R&D capabilities in the global small molecule drug sector.
We expect this acquisition will allow the company to mature as a comprehensive global pharmaceutical company, as it adds a powerful small molecule product lineup to its already strong biopharmaceutical pipeline, which includes autoimmune disease and anti-cancer drugs.