CelltrionHealthcare

This new generation of biologic medicines promises to offer a multitude of benefits, but what exactly are they and how can manufacturers navigate regulatory processes to ensure availability for those who need them?   Patients with debilitating long-term medical conditions such as rheumatoid arthritis, Crohn’s disease and psoriasis are likely to be familiar with – and thankful for – a generation of powerful hospital treatments known as biologics, which are made from proteins or other components of living organisms.   First approved in the US by the Food and Drug Administration in the 1980s, they were followed by biosimilar drugs, which mirrored the characteristics and function of existing biologics but were usually cheaper than the reference product because of comparatively lower development costs. This not only created more choice for prescribers and patients but also introduced increased competition that succeeded in reducing treatment costs for healthcare providers.   It’s no exaggeration to say that biologics and biosimilars have revolutionised medicine. Now, thanks to technological advances, these types of treatments have evolved into a new generation of biosimilars that offer further improvements.   While there is no official term for these innovative biosimilars, they are often known as biobetters.   Biosimilars are highly similar to their reference product in terms of quality, efficacy and safety, and must meet the same standards as the biologic. But biobetters go one step further – they have been tweaked to include specific attributes that deliver improvements for patients, medical staff and healthcare systems, for example, chemical modifications that can increase a drug’s half-life, lessen the body’s immune response or change a medicine’s delivery method to make it more convenient.   Put simply, biobetters could enhance patients’ quality of life, lead to better clinical outcomes and further reduce the cost burden on healthcare systems, addressing unmet needs and offering alternatives to existing treatments for both patients and healthcare professionals.   Take the immunotherapy drugs obinutuzumab and infliximab for example. Obinutuzumab is a biobetter developed from rituximab, which is used to treat inflammation in autoimmune diseases such as rheumatoid arthritis and some blood-cell cancers. Obinutuzumab has a different mechanism of action and studies have indicated improved clinical outcomes as well as higher cost-effectiveness compared to the reference product. In the case of infliximab, the subcutaneous - or under the skin - formulation demonstrated improved pharmacology parameters compared to its intravenous formulation with a different administration method.    "Biobetters could enhance patients’ quality of life, lead to better clinical outcomes and further reduce the cost burden on healthcare systems."   For those with autoimmune conditions that require long-term management, biobetters that can be delivered subcutaneously by self-administered injection, offer flexibility and remove the need to regularly travel to treatment centres. They also reduce demand for hospital beds and staffing costs to monitor patients.   Professor Shomron Ben-Horin, Director of the Institute of Gastroenterology at Sheba Medical Center in Israel, comments: “Recent studies have also shown that regular subcutaneous administration can result in more sustained therapeutic drug levels rather than experiencing drops below the target level, as can be seen with intravenous infusion, therefore offering the potential for improved patient outcomes.”   "Critics argue that a globally accepted, standardised set of regulatory guidelines would avoid duplicating clinical trials and allow medicines to come to market in a more timely fashion."   Despite the maturing of the biobetters market, there are still disparities between the approvals process in the EU and the US, as Dr HoUng Kim, Head of the Medical and Marketing Division at Celltrion Healthcare, explains:   “To date, there is no standardised guidance available from major regulatory agencies regarding the approval pathways for innovative biosimilar drugs. While the EMA [the European Medicines Agency] treats biobetters as biosimilars and allows applications for approval to follow a 'hybrid pathway’ based on data showing similar efficacy to the reference product, the FDA [the US regulatory authority] advises that drug applications are based on data from new clinical trials.”   Critics argue that a globally accepted, standardised set of regulatory guidelines would avoid duplicating clinical trials and allow medicines to come to market in a more timely fashion for the benefit of those patients who need them most. The lack of alignment also undermines confidence as patients rightly wonder why a drug is approved in Europe, for example, but not elsewhere.   While there is much potential for the biobetters market, the barriers to swift therapeutic access are challenging, not just when it comes to regulatory approval but also pricing.   “In terms of regulation of biobetters, the EMA provides an efficient regulatory track, but the pricing and reimbursement [P&R] processes also differ on a country-by-country basis,” says Dr Kim. “If there were a common or uniform P&R process shared by EU member states in the future, we believe this would facilitate commercialisation of these types of innovative products and would mean patients receive greater access to innovative treatments sooner.”   As the biopharmaceutical industry evolves, it needs to work hard to make its case for a seismic regulatory shift. Meanwhile, biopharma must continue its efforts to focus on patient centric innovation and deliver on the promise of its new products to change treatments and patients’ lives for the better.   This article was originally published in FT.com on December 14, 2021.   For more information on Sheba Medical Center's treatments and breakthroughs visit shebaonline.org.   Disclaimer : This content was paid for by Celltrion Healthcare and produced in partnership with the Financial Times Commercial department.

2023-01-17

  Molly is a 20-year-old university student, who was diagnosed with ulcerative colitis (UC) at the age of 15.  When Molly saw her first symptom, she did not talk to anyone about it because it was embarrassing,  but now she wants to break taboo around the disease as she shares her experiences with UC.  Meet Molly sharing her encouraging story and message of hope for patients living with UC.     Please could you tell us about yourself and how you were diagnosed with ulcerative colitis? Hi, I'm Molly and I'm a UC patient. I'm 20 and I've lived with UC for five years now. So I was diagnosed with UC when I was 15. The first symptom I actually noticed was blood in my stool and I actually didn't think anything of it for a few months and didn't really mention it to anyone. It was a bit of a taboo topic for a 15 year old to talk to anyone about. It’s a bit embarrassing. And then it wasn't until Christmas of that year when people started asking me about the weight loss and if I was okay. And then a few months after that, I was sent into hospital by my GP and ended up staying in hospital for 3 months and having numerous checks. And it wasn't until I got my colonoscopy and an endoscopy when I was finally diagnosed with UC.   Can you describe your experience as an ulcerative colitis patient since diagnosis? I've been on numerous different medications since diagnosis. At the very start I was on 10 tablets a day at one point, none of which were working. I was really struggling on taking them or even keeping them down whenever I took them. I really thought nothing was ever going to get me better and I was becoming really depressed within myself and very isolated. That was a very tricky time for me, I really struggled. I was just going on a further downwards path and it wasn't until around that time when I saw a psychologist and finally kind of was able to grieve my old life that I had without UC and accept this new life with UC, when I was able to finally find a medication that actually worked for me.   How has the option of at-home treatment impacted your life? Having the option of at-home treatment has impacted my life for the complete better. It has given me a complete new lease of life and has enabled me to do things that I would never be able to do before. I was able to overcome this original flare, get rid of my fatigue and be able to actually get out of bed every day and feel good with myself again. Prior to the at-home treatment I was on intravenous injections which I’d have to go into hospital for every 6 to 8 weeks and I've just returned from an 8 week holiday to Thailand, which I never would have been able to do if I was still on this intravenous medication because it wouldn’t fit the timeframe of the medication when needed. So being able to have this at home treatment has enabled me to take control of my own life and my own medication, and in a way has made me feel so much more in control of my UC as well. It's allowed me to go away for university, which I never thought I'd be able to do. I thought I'd have to be closer to home and actually to take my medication into my own terms and be able to administer it myself has really impacted me psychologically for the better.   How have you come to manage the challenges of living with ulcerative colitis? For me, the most physically challenging thing about living with UC is the fatigue that comes alongside it. And I think actually mentally the fatigue really affects me as well because of this having to say no to social interactions sometimes. But I've come to accept that actually it's okay to take a day when a day is needed. Surrounding yourself with people who understand is really important. All my close friends, they completely get when I need to take a day or when I'm sick or having a mini flare and understand that actually I just need time to recover from that, and I will be myself again and that I will be okay.   What message would you like to give to others living with ulcerative colitis? I think one of the main messages that I would like to get out there and portray to people, whether newly diagnosed or have had UC for a long time, is that it's okay not to be okay some days and that there is a light at the end of the tunnel, you won't feel like this forever, and that it's okay to reach out for help when you feel like you need it. There is nothing to be ashamed of and there are always people out there who are able to help you overcome the challenges that UC brings.

2022-10-21

[Celltrion Healthcare] Company Brochure Renewal   Celltrion Healthcare deputed its new company brochure representing the company’s commitment to guiding the future of the biopharmaceutical industry, highlighting its vision and core values as well as outlining its business strategy and product pipeline. Please click the link above to download the brochure.

2022-07-21

We interviewed Dr Philip Smith, Consultant Luminal Gastroenterologist, Royal Liverpool Hospital, Liverpool University Hospitals NHS Foundation Trust Honorary Senior Clinical Lecturer, University of Liverpool in the UK. Dr Philip Smith talked about how the COVID-19 pandemic impacted his clinical practice and an optimal way of treating inflammatory bowel disease (IBD) patients. Watch Dr Philip’s story here:

2021-12-27

We interviewed Dr Philip Smith, Consultant Luminal Gastroenterologist, Royal Liverpool Hospital, Liverpool University Hospitals NHS Foundation Trust Honorary Senior Clinical Lecturer, University of Liverpool in the UK. Dr Philip Smith talked about the challenges and future perspectives of inflammatory bowel disease (IBD) treatment facing the COVID-19 pandemic being both a patient and a physician. Watch Dr Philip’s story here:

2021-12-27

We interviewed Salvo Leone, EFCCA Chairperson who talked about unmet needs of inflammatory bowel disease (IBD) patients in existing treatment and changes in treatment approach due to the COVID-19 pandemic. He also addressed the need for attention on patients’ quality of life and quality of care. Watch Salvo’s story here:

2021-12-27

We interviewed Magdalena Sajak-Szcerba, Secretary of the Board, J-elita (Poland) who talked about challenges of living with inflammatory bowel disease (IBD), and how the COVID-19 pandemic has impacted IBD patients on a patient community level. Watch Magdalena’s story here:

2021-12-27

We interviewed people at Celltrion Healthcare who are working around the world to deliver breakthrough therapies that transform the lives of our patients. Meet Juliana Luna Paredes, Alberto Farina and Antonio Capezio, who share about what they do, why they do and why they love it.

2021-12-24

We interviewed people at Celltrion Healthcare who are working around the world to deliver breakthrough therapies that transform the lives of our patients.Meet Anthony Boteju, Ninni Raiola and Rafael Conde, who share about what they do, why they do and why they love it.

2021-12-24

  Celltrion Healthcare is the winner of the 8th Global Generics & Biosimilars Awards 2021 Celltrion Healthcare is pleased to announce that the company has received a trio at the ‘Global Generics & Biosimilars Awards 2021’ held in Milan, Italy on November 10, 2021. The three categories are ‘Global Company of the Year’, ‘Biosimilar Initiative of the Year’ and ‘Value Added Medicine initiative of the Year.’ The awards are renowned for rewarding ‘best practice’ in the generics, biosimilars and value-added medicine industries, while at the same time encouraging improvements in every aspect of the way business is conducted. We are truly grateful for the prestigious recognition for our achievements, and we remain committed to continuing innovative research of developing biosimilars and novel therapeutics.

2021-11-11