Amsterdam, Munich – Polpharma Biologics Group BV (“Polpharma Biologics”) and Bioeq AG (“Bioeq”) jointly announce that the Brazilian Health Regulatory Agency (ANVISA) has approved Ranivisio®* (ranibizumab) as a biosimilar to Lucentis®** for the treatment of debilitating retinopathies in Brazil.1
Ranivisio®, developed by Bioeq (a Joint Venture between Polpharma Biologics and Formycon AG) will be exclusively commercialized by Biomm SA in Brazil. Polpharma Biologics as manufacturer of drug substance has recently passed ANVISA inspection and received a Brazilian GMP certificate accordingly.
“By the time they reach 80 years old almost one in three people in Brazil may be experiencing vision loss or blindness due to age-related macular degeneration (AMD), placing a huge burden on the healthcare resources of South America’s largest country. ANVISA’s approval of Ranivisio® means that clinicians will now have access to a more affordable option for treating AMD, helping to alleviate the high cost of disease on both patients and society.” said Konstantin Matentzoglu, Delegated Supervisory Board Member of Polpharma Biologics Group. “Polpharma Biologics scientists played an important role in the development of Ranivisio® and we are proud that our expanding portfolio of advanced biosimilars
is helping to improve lives around the world.”
Ranivisio® belongs to the anti-VEGF therapy class of biologics that have been revolutionary in helping retinal patients maintain or gain vision and represents an additional treatment option for neovascular (wet) AMD (nAMD), diabetic macular edema (DME), diabetic retinopathy (DR), macular edema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV).1
This recent approval by ANVISA was based on a totality of evidence including analytical, nonclinical, clinical and manufacturing data. The efficacy, safety, pharmacokinetics and immunogenicity of the Bioeq-developed biosimilar ranibizumab were found to be comparable to the reference drug Lucentis® in patients with nAMD. Clinical readouts from the randomized, double-masked, parallel group, multicenter phase III study (COLUMBUS AMD) have been published in the peer-reviewed journal Ophthalmology.2
Today’s announcement follows a sequence of prior approvals of Bioeq-developed ranibizumab by stringent health authorities around the world, including the U.S. Food and Drug Administration3, European Medicines Agency4, the UK’s Medicines and Healthcare products Regulatory Agency5 and Health Canada6. To date, the Bioeq-developed biosimilar is available in 22 countries worldwide under different tradenames.
* Ranivisio® is trademark for Biomm
** Lucentis® is a registered trademark of Genentech Inc.
About Polpharma Biologics:
Polpharma Biologics is an international biotechnology company with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Using patented solutions and state-of-the-art platform technologies, Polpharma Biologics develops biosimilar products to treat a range of conditions in major therapeutic areas.
Programs at Polpharma Biologics start in cell line development and transition through technical and clinical development to commercial-scale production preparing drugs for future commercial partnerships with global pharmaceutical organizations. The expertise of Polpharma Biologics lies in the development and manufacture of medicines based on microbial and mammalian expression systems. With its cell line development center in the Netherlands and two centers of development and manufacturing in Poland, Polpharma Biologics creates growth and development opportunities for biotechnology specialists.
Learn more at www.polpharmabiologics.com.
About Bioeq:
Bioeq is a Swiss biopharmaceutical joint venture between Formycon AG and Polpharma Biologics Group BV. Bioeq develops, licenses and commercializes biosimilars. www.bioeq.ch
About Biomm:
Biomm SA was born with the mission of developing, manufacturing and commercializing biomedicines with global competitiveness, quality and accessibility, bringing the best treatments to a growing number of people. Founded in 2001, during a split-up process of a major global insulin manufacturer, Biomm is a leading Brazilian company focused in biotechnology. www.biomm.com
Important Note
This press release is for informational purposes only and does not constitute promotional material for Ranivisio® in Brazil or any other jurisdiction. The commercialization of Ranivisio® in Brazil is solely the responsibility of Biomm, the local marketing authorization holder, in accordance with all applicable Brazilian laws and regulations.
While the Bioeq-developed biosimilar ranibizumab has received marketing authorization in nearly 20 countries worldwide, including the U.S., U.K., and countries within the European Union and Canada, its availability in specific countries is subject to local regulatory approvals and may vary. This press release should not be interpreted as an indication that Bioeq-developed biosimilar ranibizumab is available for use or has been approved for sale in any particular country outside of Brazil.
Disclaimer
This press release is issued from Polpharma Biologics Group B.V. and is intended to provide worldwide information to healthcare professionals, media and (potential) investors about our global business in relation to drug development and manufacturing expertise. Although Polpharma Biologics Group B.V. is not a public company as of this date, recipients should understand that this press release contains certain forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). These statements involve inherent risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the approval and commercialization of the medicinal product, market reception, competition, changes in economic conditions and applicable laws, global regulatory developments, contractual risks and dependencies from third parties. Polpharma Biologics undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release. Moreover, Polpharma Biologics wishes to emphasize that this press release is for informational purposes only and shall not be construed as making any representation, warranties, or guarantees, either express or implied, regarding the potential approval, market reception, commercialization, or success of the medicinal product or any other product or therapy.
Media contacts
Natalia Kwiecień
natalia.kwiecien@polpharmabiologics.com
References
1 Brazilian Official Gazette. Resolution-RE nº 1828, from May 15th, 2025, published on May 19th, 2025.
2 Holz FG, Oleksy P, Ricci F. FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration. Ophthalmology 2022. 129(1):54-63
3 CIMERLI™. Prescribing Information. Available from: 761165s000lbl.pdf (fda.gov) Last accessed June 2024
4 Ranivisio® (Ranivisio – Ranibizumab). EU Summary of Product Characteristics, August 2021. Available at: https://www.ema.europa.eu/en Last accessed June 2024
5 MHRA. ONGAVIA. Available from: https://products.mhra.gov.uk/product/?product=ONGAVIA%2010%20MG%2FML%20SOLUTION%20FOR%20INJECTION Last accessed June 2024
6 Product Monograph. RANOPTO™ Available from: https://pdf.hres.ca/dpd_pm/00072813.PDF Last accessed June 2024
