Latest Industry News & Trends

Market Scope provides comprehensive coverage of the ophthalmic market. Our news stories are a combination of public and proprietary content ranging from coverage of international meetings, surgeon survey results and trends, analysis of company financial reports and public medical registries, press releases, and interviews with executives. Register today to receive free weekly email updates, our top data chart, surgeon poll results, and much more. Locked content can be accessed through a subscription to our ophthalmic industry newsletters.

Biosimilars News

11/22/2024
BiosimilarsBreakingPatentRegulationRetina
Amgen Launches Eylea Biosimilar Pavblu After Court Win Over Regeneron
Amgen Launches Eylea Biosimilar Pavblu After Court Win Over Regeneron

Amgen has launched its Eylea biosimilar, Pavblu (aflibercept-ayyh), after a victory in October in its patent fight with Regeneron. Fierce Pharma reported that a trio of US circuit judges on Oct. 22...

11/22/2024
BiosimilarsBreakingEuropeRegulationRetina
Samsung Bioepis, Biogen Gain EU Approval for Aflibercept Biosimilar Known as Opuviz
Samsung Bioepis, Biogen Gain EU Approval for Aflibercept Biosimilar Known as Opuviz

Korea’s Samsung Bioepis and Biogen, of Cambridge, Massachusetts, announced Nov. 18 that the European Commission had granted marketing authorization for Opuviz (aflibercept-yszy), an Eylea biosimila...

11/15/2024
BiosimilarsBreakingEuropeRegulationRetina
Sandoz Gains EU Approval for its Aflibercept Biosimilar Known as Afqlir
Sandoz Gains EU Approval for its Aflibercept Biosimilar Known as Afqlir

Swiss drugmakerSandoz announced Nov. 15 that the European Commission had granted marketing authorization for Afqlir (aflibercept), an Eylea biosimilar. Afqlir, available as a 2 mg vial kit and pre-...

10/15/2024
BiosimilarsEuropeNewsletterRegulationRetina
Europe’s CHMP Recommends Two Aflibercept Biosimilars for Approval
Europe’s CHMP Recommends Two Aflibercept Biosimilars for Approval

Europe’s Committee for Medicinal Products for Human Use (CHMP) issued positive opinions on Sept. 19 for two new aflibercept (Eylea) biosimilars—Afqlir from Swiss drugmaker Sandoz and Opuviz, which ...

9/27/2024
BiosimilarsBreakingPharmaRetina
Amgen’s Pavblu is Fifth Aflibercept Biosimilar to Gain US Approval in 2024
Amgen’s Pavblu is Fifth Aflibercept Biosimilar to Gain US Approval in 2024

The FDA has approved Amgen’s Pavblu (aflibercept-ayyh), making it the fifth Eylea biosimilar to reach the milestone in the US in 2024. FDA records show Pavblu was approved Aug. 23. Labeling shows i...

9/27/2024
BiosimilarsBreakingEuropeRetina
Europe’s CHMP Recommends Two Aflibercept Biosimilars for Approval
Europe’s CHMP Recommends Two Aflibercept Biosimilars for Approval

Europe’s Committee for Medicinal Products for Human Use (CHMP) issued positive opinions on Sept. 19 for two new aflibercept (Eylea) biosimilars—Afqlir from Swiss drugmaker Sandoz and Opuviz, which ...

8/21/2024
BiosimilarsCornealDealsDry EyeEuropeGene TherapyGenericsIndustryLow VisionNewsletterOcular CancerPharmaPresbyopiaRegulationRetina
August 2024 Ophthalmic News Briefs
August 2024 Ophthalmic News Briefs

Ireland-based Mallinckrodt announced Aug. 6 that its H.P. Acthar Gel single-dose prefilled SelfJect injector was available in the US. The US FDA approved the supplemental new drug application for t...

8/16/2024
BiosimilarsBreakingCataractDiagnosticDry EyeGlaucomaLaserOcular CancerRefractiveRetinaRevenueSurgical
Q2-2024 Ophthalmic Revenue Roundup for AbbVie, Carl Zeiss Meditec, Amgen, STAAR, Astellas, Immunocore, Tarsus, Biogen, Lensar, and Iridex
Q2-2024 Ophthalmic Revenue Roundup for AbbVie, Carl Zeiss Meditec,  Amgen, STAAR, Astellas, Immunocore, Tarsus, Biogen, Lensar, and Iridex

AbbVie, of North Chicago, Illinois, reported July 25 that Q2-2024 net revenue for its eye care products totaled $533 million, a 13.3 percent decline (-10.9 percent cc) from $617 million in Q2-2023....

8/16/2024
BiosimilarsBreakingRegulationRetina
US FDA Approves Aflibercept (Eylea) Biosimilar from Sandoz
US FDA Approves Aflibercept (Eylea) Biosimilar from Sandoz

Swiss drugmaker Sandoz announced Aug. 12 that the US FDA had approved Enzeevu, an aflibercept (Eylea) biosimilar, for wet age-related macular degeneration (AMD). Enzeevu (aflibercept-abzv) will be ...

8/2/2024
BiosimilarsBreakingDry EyeEuropeRegulationRetina
Novaliq Receives Positive CHMP Opinion for Vevizye in Dry Eye
Novaliq Receives Positive CHMP Opinion for Vevizye in Dry Eye

Germany’s Novaliq announced July 29 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended marketing authorization in the European Union for Vevi...

7/23/2024
BiosimilarsCornealFundingGene TherapyMyopiaNewsletterPresbyopiaRetina
Beacon Leads Latest Ophthalmic Fundraising with $170 Million in Series B
Beacon Leads Latest Ophthalmic Fundraising with $170 Million in Series B

Beacon Therapeutics led recent ophthalmic fundraising efforts with $170 million in Series B funding to advance its candidates for retinal disease. Financing announced in the past four weeks totaled...

7/23/2024
BiosimilarsClinical TrialCornealDealsDry EyeEuropeGene TherapyGlaucomaIndiaIndustryMyopiaNewsletterRegulationRetina
July 2024 Ophthalmic News Briefs
July 2024 Ophthalmic News Briefs

Bausch + Lomb announced July 23 that it had acquired dry eye diagnostic company Trukera Medical from its private equity owner, AccelMed Partners, and other shareholders. No financial details were d...

7/11/2024
BiosimilarsBreakingEuropeRegulationRetina
Altos Biologics Files for European Approval of Aflibercept (Eylea) Biosimilar
Altos Biologics Files for European Approval of Aflibercept (Eylea) Biosimilar

Altos Biologics has submitted a marketing authorization application to the European Medicines Agency (EMA) for ALT-L9, an aflibercept (Eylea) biosimilar, according to a joint announcement by Altos ...

7/5/2024
BiosimilarsBreakingRegulationRetina
US FDA Approves Aflibercept (Eylea) Biosimilar from Formycon, Klinge
US FDA Approves Aflibercept (Eylea) Biosimilar from Formycon, Klinge

German companies Formycon and Klinge Biopharma announced June 28 that the US FDA had approved their aflibercept (Eylea) biosimilar for wet age-related macular degeneration (AMD), diabetic macular e...

5/24/2024
BiosimilarsBreakingRegulationRetina
US FDA Approves First Interchangeable Biosimilars to Eylea
US FDA Approves First Interchangeable Biosimilars to Eylea

The FDA announced May 20 that it had approved the US’ first interchangeable biosimilars to Eylea (aflibercept)— Yesafili, from India’s Biocon Biologics, and Opuviz, which was jointly developed by B...

5/24/2024
BiosimilarsBreakingDry EyeGlaucomaLaserRetinaRevenue
Q1-2024 Ophthalmic Revenue Roundup for AbbVie, Iridex, and Biogen
Q1-2024 Ophthalmic Revenue Roundup for AbbVie, Iridex, and Biogen

AbbVie, of North Chicago, Illinois, reported April 26 that its Q1-2024 eye care net revenue totaled $538 million, an 11.7 percent decline (-10.4 percent cc) from $608 million in Q1-2023. Restasis r...

5/17/2024
BiosimilarsBreakingDealsRetina
Xbrane, Stada Partner with Valorum to Commercialize Ranibizumab Biosimilar Candidate in US
Xbrane, Stada Partner with Valorum to Commercialize Ranibizumab Biosimilar Candidate in US

Partners Xbrane Biopharma, of Sweden, and Germany’s Stada announced May 10 that they had entered into an exclusive licensing agreement with biosimilar company Valorum Biologics to market their rani...

4/26/2024
BiosimilarsBreakingRegulationRetina
US FDA Rejects Xbrane’s Ranibizumab Biosimilar, Citing Analysis and Manufacturing Issues
US FDA Rejects Xbrane’s Ranibizumab Biosimilar, Citing Analysis and Manufacturing Issues

Sweden’s Xbrane Biopharma announced April 21 that the US FDA had issued a complete response letter rejecting Xbrane’s ranibizumab biosimilar, branded in Europe as Ximluci. The company said regulato...

4/24/2024
BiosimilarsNewsletterRegulationRetina
US FDA Backs Call to Eliminate Interchangeability Designation for Biosimilars
US FDA Backs Call to Eliminate Interchangeability Designation for Biosimilars

A US FDA official has expressed support for measures before Congress to remove the interchangeability designation for biosimilars, claiming that the two-tier system is only causing confusion. It ca...

4/19/2024
BiosimilarsBreakingRegulation
US FDA Backs Call to Eliminate Interchangeability Designation for Biosimilars
US FDA Backs Call to Eliminate Interchangeability Designation for Biosimilars

A US FDA official has expressed support for measures before Congress to remove the interchangeability designation for biosimilars, claiming that the two-tier system is only causing confusion. Under...

3/15/2024
BiosimilarsBreakingRegulationRetina
Formycon’s Ranibizumab Biosimilar Gains Approval in Saudi Arabia, Will Be Marketed as Ravegza
Formycon’s Ranibizumab Biosimilar Gains Approval in Saudi Arabia, Will Be Marketed as Ravegza

Germany’s Formycon announced March 11 that FYB201 (ranibizumab), a biosimilar to Lucentis, had received marketing authorization from the Saudi Food & Drug Authority. Jordan’s MS Pharma is Formycon’...

3/8/2024
BiosimilarsBreakingIOLLaserOcular CancerRetinaRevenue
2023 Ophthalmic Revenue Roundup for Immunocore, RxSight, Lensar, and Biogen
2023 Ophthalmic Revenue Roundup for Immunocore, RxSight, Lensar, and Biogen

UK-headquartered Immunocore reported Feb. 28 that its 2023 net product revenue from Kimmtrak (tebentafusp) was $238.7 million, a 70 percent increase over $140.7 million in 2022. The 2023 total was ...

1/26/2024
BiosimilarsBreakingDealsRetina
Sandoz Acquires Ranibizumab Biosimilar Cimerli from Coherus for $170 Million Up Front
Sandoz Acquires Ranibizumab Biosimilar Cimerli from Coherus for $170 Million Up Front

Swiss drugmaker Sandoz announced Jan. 22 that it had signed an agreement to acquire the US ranibizumab (Lucentis) biosimilar Cimerli from Coherus BioSciences for $170 million up front. The deal inc...

1/26/2024
BiosimilarsBreakingFundingRegulationRetina
Xbrane Reports Plan to Raise Up to $40.2 Million to Launch Ranibizumab Biosimilar Ximluci
Xbrane Reports Plan to Raise Up to $40.2 Million to Launch Ranibizumab Biosimilar Ximluci

Swedish biosimilar drug developer Xbrane reported Jan. 22 a rights issue of units to raise SEK 343 million ($32.8 million, converted on Jan. 22, 2024) in funding. Xbrane said the offering primarily...

12/14/2023
BiosimilarsEmergingGene TherapyGlaucomaNewsletterRetina
Emerging Companies Pursuing Ophthalmic Indications, December 2023
Emerging Companies Pursuing Ophthalmic Indications, December 2023

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

12/8/2023
BiosimilarsBreakingEmergingIndiaRetina
India’s Enzene Biosciences Launches Ranibizumab Biosimilar for Wet AMD
India’s Enzene Biosciences Launches Ranibizumab Biosimilar for Wet AMD

Enzene Biosciences announced in November that it had launched a ranibizumab biosimilar for the treatment of wet age-related macular degeneration (AMD). The product references Lucentis, which is sol...

10/24/2023
BiosimilarsEuropeNewsletterRegulationRetina
Biocon Receives EU Marketing Approval for Yesafili, an Aflibercept Biosimilar
Biocon Receives EU Marketing Approval for Yesafili, an Aflibercept Biosimilar

India’s Biocon Biologics announced Sept. 20 that the European Commission had granted marketing authorization in the European Union for Yesafili, an aflibercept (Eylea) biosimilar. Yesafili is appro...

10/6/2023
BiosimilarsBreakingRetina
Coherus Says Cimerli (Ranibizumab Biosimilar) Sales Exceed 100 Thousand Doses in First Year
Coherus Says Cimerli (Ranibizumab Biosimilar) Sales Exceed 100 Thousand Doses in First Year

Coherus BioSciences announced Oct. 4 that sales of Cimerli (ranibizumab-eqrn), its Lucentis biosimilar, have exceeded 100 thousand doses since its US commercial launch on Oct. 3, 2022. Cimerli was ...

9/29/2023
BiosimilarsBreakingEuropeRegulationRetina
Biocon Receives EU Marketing Approval for Yesafili, an Aflibercept Biosimilar
Biocon Receives EU Marketing Approval for Yesafili, an Aflibercept Biosimilar

India’s Biocon Biologics announced Sept. 20 that the European Commission had granted marketing authorization in the European Union for Yesafili, an aflibercept (Eylea) biosimilar. Yesafili is appro...

9/1/2023
BiosimilarsBreakingRetinaRevenue
Q2-2023 Ophthalmic Revenue Roundup for Horizon and Biogen
Q2-2023 Ophthalmic Revenue Roundup for Horizon and Biogen

Horizon Therapeutics, of Dublin, Ireland, reported Aug. 8 that its Q2-2023 Tepezza net sales totaled $446 million, a 7 percent decrease from $479.8 million in Q2-2022. The company said expansion of...

7/28/2023
BiosimilarsBreakingDealsRetina
Stada, Xbrane Look for New Partner After Deal with Bausch + Lomb for Ranibizumab Biosimilar Ends
Stada, Xbrane Look for New Partner After Deal with Bausch + Lomb for Ranibizumab Biosimilar Ends

Sweden’s Xbrane Biopharma and its partner Stada, of Germany, announced July 24 that they were looking for a new partner to commercialize their ranibizumab biosimilar in the US and Canada, after the...

7/28/2023
BiosimilarsBreakingEuropeRegulationRetina
Aflibercept Biosimilar Candidate from Biocon Gains Positive CHMP Opinion
Aflibercept Biosimilar Candidate from Biocon Gains Positive CHMP Opinion

India’s Biocon Biologics announced July 24 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion recommending approval of Yesafili...

Want to Read the Full Article?

Register A Corporate Account

A corporate account gives you access to licensed reports and subscriptions, the latest news, a personalized dashboard, and weekly emails with news and data.

Select one or more
Select one or more