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Heidelberg Engineering: Enhancing the Patient Journey

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Although off-label repackaged bevacizumab syringes appear to satisfy an urgent clinical and financial need for patients with a variety of retinal disorders, they are known to be associated with considerable public health concerns due to the risks posed to patients from compounding pharmacies’ lack of compliance with a variety of FDA requirements.

Intravenous bevacizumab repackaged for intravitreal use: Making the sight-saving treatment safer

The European Commission provided a positive opinion from the European Medicines Agency (EMA) Committee for Advanced Therapies, providing an Advanced Therapy Medicinal Product (ATMP) classification to OCU400 (Ocugen, Inc.). OCU400 is the first gene therapy from the biotechnology company to move forward into Phase 3 with a broad retinitis pigmentosa (RP) indication.

ATMP classification is given to medicines that allow for innovative opportunities for the treatment of disease, thus accelerating the regulatory review timeline of the new gene therapy. The classification will also allow for further collaboration between Ocugen and the EMA, with the EMA in place for scientific advice and protocol assistance as the company pushes for Marketing Authorisation Application (MAA) filing in 2026.

“Receiving ATMP classification is another significant milestone toward bringing OCU400 to the market in Europe,” said Shankar Musunuri, chairman, CEO and co-founder of Ocugen. “This designation makes it possible to stay on track with our clinical and commercial strategy and potentially provide this novel modifier gene therapy candidate to all RP patients in the United States and Europe by 2027.”

Besides the EMA, the FDA has also acknowledged that the Phase 3 trial of OCU400 can suffice for Biologics License Application (BLA) and MAA submissions. Ocugen, Inc. plans to file simultaneously in the US and Europe after completion of the trial.

Currently, the Phase 3 OCU400 trial is undergoing enrollment, and the study has a sample size of 150 participants. Patients 8 years old and older with early through late-stage advancement of RP are being recruited to take part in the study.

“We are encouraged by the EMA’s recognition of OCU400 as the Phase 3 liMeliGhT clinical trial advances,” Huma Qamar, chief medical officer at Ocugen, said. “I look forward to working collaboratively with the EMA to address the unmet medical need that remains for nearly 98% of the RP patient population.”

Ocugen Announces Positive Opinion of European Medicines Agency’s Committee for Advance Therapies for Advanced Therapy Medicinal Product Classification for Modifier Gene Therapy Candidate OCU400 for Retinitis Pigmentosa. News release. Ocugen. Published February 3, 2025. Accessed February 3, 2025. https://www.globenewswire.com/news-release/2025/02/03/3019337/0/en/Ocugen-Announces-Positive-Opinion-of-European-Medicines-Agency-s-Committee-for-Advanced-Therapies-for-Advanced-Therapy-Medicinal-Product-Classification-for-Modifier-Gene-Therapy-Ca.html

OCU400 is the first gene therapy from the biotechnology company to move forward into Phase 3 with a broad retinitis pigmentosa (RP) indication

Ocugen, Inc. receives European Medicines Agency ATMP designation for new gene therapy OCU400

On 13 January, Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd., announced it would partner with Klinge Biopharma GmbH and Formycon AG in commercialising FYB203, Formycon’s biosimilar candidate to aflibercept (Eylea, Regeneron Pharmaceuticals Inc.) in designated regions of Europe.

 On 5 February, Formycon announced that Klinge Biopharma had also concluded an exclusive license agreement with Lotus Pharmaceutical.

 This new agreement will enable commercialisation of the product throughout the Asia-Pacific region. Pending regulatory approval, the product will be marketed under the brand name AHZANTIVE.

Under these agreements, Teva will lead the commercialisation effort in designated regions of Europe, excluding Italy, and in Israel. Lotus Pharmaceutical will lead commercialisation in Indonesia, Malaysia, the Philippines, Singapore, Taiwan, Thailand and Vietnam, as well as within the Special Administrative Region Hong Kong.

Previously, Teva was established as the European commercialisation partner of FYB201, Formycon's biosimilar to ranibizumab (Lucentis). Nicola Mikulcik, hief business officer of Formycon, commented on the expansion of the partnership. “With Teva, we are gaining a strong and proven partner for FYB203 in the major parts of Europe and Israel. Teva is already marketing our FYB201 ranibizumab biosimilar (Ranivisio/Ongavia) in Europe and can synergistically leverage an existing commercial infrastructure and well-established distribution channels in the ophthalmology field,” she said in the press release.

 “We are pleased to build on this trusted and successful collaboration. Particularly noteworthy is Formycon’s first-time responsibility for managing the entire commercial supply chain of the finished product.”

Like its reference product, the biosimilar FYB203 is an anti-vascular endothelial growth factor (VEGF) agent used to treat retinal disease. Chief among those indications is neovascular age-related macular degeneration (AMD), also known as wet AMD.

In November 2024, the European Medicines Agency's Committee for Medicinal Products of Human Use issued a positive recommendation for marketing authorisation of FYB203, under the brand names AHZANTIVE/Baiama. The European Commission is expected to announce a response to the authorisation application in late January 2025.

In June 2024, the US Food and Drug Administration (FDA) approved the biosimilar FYB203, also known as aflibercept-mrbb. In a press release at that time, the company stated3 that FDA approval was rooted in the company's “comprehensive data package” that included “analytical, pre-clinical, clinical and manufacturing data.” The data showed that FYB203 demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference product in patients with neovascular AMD.

Teva Announces Collaboration to Commercialize Formycon’s Biosimilar Candidate to Eylea® (aflibercept) in major parts of Europe and in Israel. News release. Teva Pharmaceutical Industries Ltd. Published January 13, 2025. Accessed January 13, 2025. https://www.globenewswire.com/news-release/2025/01/13/3008103/0/en/Teva-Announces-Collaboration-to-Commercialize-Formycon-s-Biosimilar-Candidate-to-Eylea-aflibercept-in-major-parts-of-Europe-and-in-Israel.html

Lotus Pharmaceutical becomes strategic partner for the commercialization of Formycon’s Eylea® biosimilar FYB203/AHZANTIVE® in the Asia-Pacific Region. News release. Formycon AG. Published February 5, 2025. Accessed February 5, 2025.

Harp M. FDA approves Formycon’s biosimilar to Eylea, aflibercept-mrbb (Ahzantive). Ophthalmology Times. Published July 2, 2024. Accessed January 13, 2025. https://www.ophthalmologytimes.com/view/fda-approves-formycon-s-biosimilar-to-eylea-aflibercept-mrbb-ahzantive-

The commercialisation agreements for the biosimilar to aflibercept (Eylea) cover Israel, major parts of Europe and the Asia-Pacific Region

Teva partners with Klinge Biopharma, Lotus Pharmaceutical for commercialisation of Formycon’s FYB203 (biosimilar aflibercept)

Over the last 15 years, biosimilars have become a major feature of the health care landscape. Physicians in many disciplines, particularly oncology and immunology, have embraced biosimilars. However, access to educational resources on these powerful biologics can be inconsistent, and in turn, some ophthalmologists who could benefit from the adoption of biosimilars are left in the dark.

The real-world application of biosimilars was the focus of discussion for Martin Zinkernagel, MD, PhD, chair of the Department of Ophthalmology at the University Hospital of Bern, Switzerland, and Paolo Lanzetta, MD, professor of ophthalmology and chairman of the Department of Medicine-Ophthalmology at the University of Udine in Italy. In their discussion, the experts addressed several common questions, framed around the phase 3 clinical trial for biosimilar SB11 (BYOOVIZ) from Biogen. SB11 is approved in Europe and the United Kingdom. Like the reference product ranibizumab (Lucentis), SB11 is approved for the treatment of retinal disease including neovascular age-related macular degeneration (nAMD).

Addressing physicians’ levels of familiarity with biosimilars, Dr Lanzetta attributed much of the variation to regulatory discrepancies. “The uptake of biosimilars varies throughout Europe by country and by product,” he said. “Obviously, variation in the uptake of biosimilars [is] influenced by government involvement, reimbursement issues and tender procurement policies.” Recent survey data have revealed gaps in awareness across Europe and in the United States on the efficacy and safety of biosimilars for retinal diseases, Dr Lanzetta said, especially in terms of “real-world data.”

In a clinical application, Dr Lanzetta said, biosimilars may exhibit minor differences from the reference products, but they aren’t considered to have significant impact on the efficacy or safety profile. Typically, the biosimilar and reference medicine must have the same posology and route of administration, with few exceptions, he added.

Dr Lanzetta also said that in the last 10 years, the European Medicines Agency (EMA) has approved the highest number of biosimilars worldwide.

 “And this means, to us physicians, having both the possibility to have experience on their use in terms of safety and evaluating the efficacy after that,” he explained.

One common misconception about biosimilars is that these therapeutics are interchangeable with the idea of generic medicines. But there is a key indicator that biosimilars are unique: the cost. “While generic medicines are marketed at a significantly lower price than name brand ones, why do we not see the same level of cost savings with biosimilars?” Dr Zinkernagel asked.

Dr Lanzetta explained that biosimilars are developed via a rigorous, complex and highly regulated manufacturing process. “Generics are simple chemical medicines or agents, which is not the case for biosimilars and biologics,” he said. “Unlike generics, biologics, and therefore biosimilars as well, are very complex; they’re very difficult to copy. And the development processes are patented and proprietary to the originators.” The proprietary nature of biologic development, he added, is why biosimilars may have differences from their originators.

Prof Zinkernagel and Dr Lanzetta used data from the SB11 phase 3 trial to expand upon the capabilities of biosimilars. Prof Zinkernagel detailed the study: over 700 patients were included in the randomised, double-masked, parallel-group multicentre trial. Over 52 weeks, investigators evaluated the efficacy and the safety profile of this biosimilar SB11 in comparison with monthly ranibizumab for the treatment of nAMD.

“Patients with neovascular AMD were included, [with a] visual acuity range between 20/40 and 20/200,” Prof Zinkernagel said. “[Patients] were randomised in a 1:1 ratio to either have the originator or the biosimilar every 4 weeks from baseline up to week 48.”

Primary end-points were change from baseline in best corrected visual acuity at week 8 and change from baseline in central subfield thickness at week 4. The pre-specified secondary efficacy end-points included longer-term assessments of change from baseline in visual acuity, and the proportion of participants who lost fewer than 15 letters or who gained 15 or more letters in visual acuity from baseline at weeks 24 and 52.

“Other secondary end-points included, of course, change from baseline in central subfield thickness and central retinal lesion thickness at week 24, as well as change from baseline in choroidal neovascularisation [CNV] size and proportion of participants with active CNV leakage seen via OCT [optical coherence tomography] at week 24,” Prof Zinkernagel continued. Describing the results, he said, “When you look at the visual acuity improvements, it’s really equivalent. You have equivalence between the originator and the biosimilar, and the same holds true for a decrease in central retinal thickness. So the curves are basically the same, and also the secondary end-points.”

Prof Zinkernagel also spoke about the immunogenicity outcomes of the SB11 trial, as immunogenicity reactions have been a common problem in past assessments of anti–vascular endothelial growth factor (VEGF) agents. Along with detrimental effects to visual acuity, immunogenicity reactions can also lead to vasculitis and vitritis.

“Now, in this trial, the overall cumulative incidence of anti-drug antibodies, antibodies reacting against this specific drug up to week 52, was very low,” Prof Zinkernagel said. “For the SB11 biosimilar, it was 4.2%, and for the originator it was 5.5%. So very, very similar.”

He also noted that most antibodies were non-neutralising, which generally indicates a weak antibody response. “Furthermore, no statistical or clinically relevant differences in the incidence of anti-drug antibodies and neutralising antibodies were observed between treatment groups at any of the time points,” Prof Zinkernagel explained.

Dr Lanzetta highlighted the unique potentialities for anti-VEGF therapies as an area where physicians can consider treating patients with a biosimilar. “You can either switch a patient from the originator, obviously, or you can also consider treating with a biosimilar treatment-naive patients who may benefit…from being treated with that reference agent or originator agent,” he said. When to deploy a biosimilar will depend on many factors, including the locality where a patient is being treated. “Europe has different countries, different health care systems,” Dr Lanzetta said. “You may consider treating with the biosimilar patients who may not be strictly adherent to the cost of therapy and the frequency of treatment because of some cost issues.”

Just as education on biosimilars is vital to practitioners, awareness and education resources for patients are vital, too. “We spend a lot of time with our patients in letting them know that biologics did undergo a very rigorous approval process through studies, efficacy and safety studies,” Dr Lanzetta emphasised. This education is vital to getting patients on board with biosimilars, and it sparks enthusiasm about the potential benefits. “Once they do understand that, I think they will be very prone to receive a biosimilar; [it’s] in their interest and in the interest of the community, the whole community of patients, and in the interest of the health care system,” Dr Lanzetta said.

1. Biosimilars in the EU: information guide for healthcare professionals. European Medicines Agency. Updated December 2, 2019. Accessed October 3, 2023. 

https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pd

Editor’s note: A prior version of this article contained a misspelling of the product name BYOOVIZ. It has been corrected. We regret the error.

How biosimilars expand treatment options for patients with retinal disease

From 13-14 June, Heidelberg Engineering will hold its 21st International SPECTRALIS Symposium (ISS) in its eponymous hometown of Heidelberg, Germany. The event will be the first ISS held in the newly-opened Heidelberg Congress Center. Following the conclusion of the first day’s scientific programme, attendees may board one of two river boats for a cruise down the Neckar, which promises scenic views of historic Heidelberg.

The Queen Silvia will offer a seated dinner cruise, and a smaller boat alongside will offer food, drinks and music.

Both days of the meeting will feature welcome messages from course director Frank Holz, MD, FEBO, FARVO. Holz is professor and chair of the Department of Ophthalmology at University of Bonn, Germany. During the ISS, he will serve as co-chair for two sessions, and will present his own lecture, sharing results from the MACUSTAR study demonstrating imaging-based progression markers in intermediate AMD.

Below, find the schedule of topics, including programme chairs, for the ISS.

 For more information about the ISS, including information on digital poster presentations, tours of the SkyLabs tower and registration, access the 

Welcome address from course director Professor Frank G. Holz

Chaired by SriniVas R. Sadda, MD, FARVO, and Giovanni Staurenghi, MD, FARVO, FEBO

Lecture topics will include mechanistic and biomarker discovery, unlocking systemic insights with multimodal retinal imaging in the NICOLA study, approaching neurodegeneration with a focus on corneal imaging, and more.

Chaired by Balwantray Chauhan, PhD, and Leopold Schmetterer, MSc, PhD

Lectures will address many challenges and opportunities in optical coherence tomography (OCT), including high-res OCT of atrophic and precursor lesions in AMD, unveiling new insights in diabetic maculopathy with high-res OCT, first reactions to a new high-res imaging platform.

Chaired by Prof Holz and Adnan Tufail, MBBS, MD, FRCOphth

Topics in this session include holographic OCT for retinal function, in vivo functional imaging of singular retinal ganglion cells with two-photon imaging, use of fluorescence lifetime imaging ophthalmoscopy (FLIO) to study silent disease progression in Alzheimer, Parkinson and MS and other topics.

Chaired by Karl Csaky, MD, PhD, and Robert P. Finger, MD, PhD

Multiple presentations using the MACUSTAR data to better understand retinal function and structure, using OCT-determined anatomical features as clinical trial endpoints, and more

From 17:45 to 18:30, two team members from NASA, the US-based National Aeronautics and Space Administration, will deliver the keynote address, “A journey into space: Völlig losgelöst!”

Warren “Woody” Hoburg reported for duty as part of the NASA astronaut class of 2017. He holds a bachelor’s degree in aeronautics and astronautics from the Massachusetts Institute of Technology (MIT) and a doctorate in electrical engineering and computer science from the University of California, Berkeley. At the time of his selection for the astronaut programme, he was an assistant professor at MIT. Astronaut Hoburg launched to the International Space Station as Pilot of NASA’s SpaceX Crew-6 mission in March 2, 2023 and has logged a total of 186 days in space on his first flight.

Tyson J. Brunstetter, MBA, OD, PhD, FAAO, FAsMA, is a US Navy aerospace optometrist at the NASA Johnson Space Center in Houston, Texas. He earned his OD, MS and PhD from the Ohio State University.

 He the clinical lead for NASA’s research into spaceflight-associated neuro-ocular syndrome (SANS), a condition which is common among astronauts, especially during long-duration missions.

Follow along with all of our ISS coverage

Welcome note from course director Professor Frank G. Holz

Chaired by Roberto Gallego Pinazo, MD, PhD, and Seung-Young Yu, MD, PhD

Presentations in the artificial intelligence (AI) session will address use of AI in FLIO (including findings from the AI-READI project), AI-based evaluation of dry AMD biomarkers and fluid monitoring in nAMD and GA.

Chaired by Anat Loewenstein, MD, and Ursula Schmidt-Erfurth, MD

Topics will include pearls for avoiding misdiagnosis when encountering hyperreflective vitreous opacities in children, OCT and OCT-A in patients with sickle cell retinopathy, OCT-based outcome measures in paediatric gene therapy, and more.

Chaired by Prof Holz and James Talks, MA, MB Bchir, MRCP, FRCOphth

Topics in the final session include remote patient monitoring, the continued relevance of multimodal imaging, extreme telemedicine during long-duration space travel and closing the “gaps” between hospitals and communities with retinal imaging.


1. International SPECTRALIS Symposium June 13-14 in Heidelberg. Heidelberg Engineering Academy. Accessed June 9, 2025. https://academy.heidelbergengineering.com/course/view.php?id=1246

2. International SPECTRALIS Symposium and Beyond: Our Best Program. Heidelberg Engineering Academy. Accessed June 9, 2025. https://www.academy.heidelbergengineering.com/hedata/e-learning/Totara/Dateien/ScientificProgram_ISS2025_Heidelberg.pdf

3. Warren Hoburg, NASA Astronaut. NASA. Accessed June 9, 2025. https://www.nasa.gov/people/warren-hoburg/

4. Bio: Tyson J. Brunstetter. United Mitochondrial Diseased Mar Foundation. Published March 2022. Accessed June 9, 2025. https://www.umdf.org/wp-content/uploads/2022/03/2022MitoMedBrunstetterBio.pdf 

More than 35 lectures across seven topics, plus a keynote address, will be featured during the meeting

Full list of topics at the International SPECTRALIS Symposium in Heidelberg, Germany

Rayaz Malik, MBChB, PhD, shares his presentation, titled An eye on neurodegenerative diseases: Challenging the dogma, at this year's International SPECTRALIS Symposium

During the second weekend of June, Heidelberg Engineering will open its new Heidelberg Congress Center for the 21st International SPECTRALIS Symposium (ISS). The meeting in Heidelberg, Germany, begins on Friday, 13 June with a scientific programme including topics like oculomics, age-related macular degeneration and distributed care models.

Rayaz Malik, MBChB, PhD, a professor of medicine at Weill Cornell Medicine - Qatar, spoke with 

 about his presentation. It's titled "An eye on neurodegenerative diseases: Challenging the dogma." During his lecture, Prof Malik demonstrated the potential of corneal confocal microscopy as an effective diagnostic tool for patients with markers of neurodegenerative disease.

In the first of two video interviews, Prof Malik explained why the cornea is a particularly viable source of biomarkers and described the unique anatomical features of the anterior segment which are the focus of his research. Watch the full video to hear what he shared at the ISS.

Prof Malik shared his presentation, titled "An eye on neurodegenerative diseases:
Challenging the dogma," at this year's International SPECTRALIS Symposium 

The cornea is the unsung hero of diagnosing neurodegeneration, says Rayaz Malik, MBChB, PhD

Formycon AG announced that the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA) has granted marketing authorisation for FYB201 (Ranivisio), a biosimilar to Lucentis (ranibizumab, Genentech Inc.). FYB201 was developed by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV.

Along with the regulatory decision, Formycon announced it has established a commercialisation partnership with the Brazilian pharmaceutical company Biomm. The company focuses on the development, manufacturing and distribution of biopharmaceutical drugs, including biosimilars.

Biomm's product launch of FYB201 is expected to occur in the fourth quarter of 2025, marking the beginning of a phased market rollout of FYB201 across Latin America. The regional regulatory authorities in Peru, El Salvador, Honduras and the Dominican Republic have already granted marketing authorisations for the biologic drug. Further approvals and product launches in Central and South America are planned through early 2027, according to the press release issued by Formycon.

Formycon Chief Business Officer Nicola Mikulcik stated, "The marketing approval of FYB201/Ranivisio in Brazil underlines our mission to improve access to high-quality biologic drug therapies, especially in countries where the use of high-cost biologics is quite limited today. We are extremely pleased to offer a safe, effective and affordable treatment option for the growing patient population with severe retinal diseases in Brazil.”

FYB201 is used to treat severe visual impairments such as wet age-related macular degeneration and other retinopathies. The biosimilar is currently available in a total of 21 countries in Europe, North America, the Middle East and North Africa.

1. Lucentis® biosimilar FYB201/Ranivisio® (ranibizumab) approved in Brazil. Press release. Formycon AG. Published June 5, 2025. Accessed June 5, 2025. https://www.formycon.com/blog/press-release/lucentis-biosimilar-fyb201-ranivisio-ranibizumab-in-brasilien-zugelassen/

Brazilian ANVISA has granted marketing authorisation for FYB201 (Ranivisio), a biosimilar to Lucentis.

Dr Szilárd Kiss

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