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Biosimilars News
Appeals Court Upholds Injunctions Blocking Eylea Biosimilars from Samsung Bioepis and Formycon
In a victory for Regeneron, the US Court of Appeals for the Federal Circuit issued a ruling Jan. 29 upholding preliminary injunctions that block Samsung Bioepis and Formycon from launching their ap...
Aflibercept Biosimilar Candidate from Amgen Gains Positive CHMP Opinion
Europe’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion Jan. 30 for an aflibercept (Eylea) biosimilar from Amgen, under the names Pavblu and Skojoy. The biosimilar ...
Formycon, Klinge Gain EU Approval for Eylea Biosimilar Under Brand Names Ahzantive and Baiama
German companies Formycon and Klinge Biopharma announced Jan. 20 that the European Commission had granted marketing authorization for their Eylea biosimilar, under the brand names Ahzantive and Bai...
2024 in Review: Flurry of Eylea Biosimilars Approved; Most Blocked in US by Lawsuits
The FDA was in a hurry in 2024 to get low-cost competitors to Eylea into the US market. Regeneron wasn’t. The FDA approved 12 drugs for ophthalmic indications in 2024, including four generic glauco...
January 2025 Ophthalmic News Briefs
China’s Eyebright Medical announced Jan. 7 that its phakic intraocular lens, the Loong Crystal PR, had received certification as a Class III medical device from the country’s National Medical Produ...
Teva Signs Deal to Commercialize Formycon’s Aflibercept Biosimilar Candidate in Israel and Most of Europe
Israel’s Teva Pharmaceuticals announced Jan. 13 that it had entered into a collaboration with German companies Klinge Biopharma and Formycon for the semi-exclusive commercialization of FYB203, Form...
Xbrane Resubmits BLA to US FDA for Ranibizumab Biosimilar
Sweden’s Xbrane Biopharma announced Dec. 31 that it had resubmitted the biologics license application (BLA) to the US FDA for its Lucentis (ranibizumab) biosimilar candidate. The FDA issued a compl...
Ophthalmic Revenue Roundup for Carl Zeiss Meditec, Amgen, Biogen
Carl Zeiss Meditec reported Dec. 11 that ophthalmology revenue for its full fiscal year 2023/2024, which ended Sept. 30, was €1.59 billion (US $1.7 billion, converted Dec. 11, 2024), an increase of...
Aflibercept Biosimilar Candidate from Celltrion Gains Positive CHMP Opinion
South Korea’s Celltrion announced Dec. 15 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued positive opinions recommending approval of three of i...
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...
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...
Kyung-Ah Kim, PhD, Named President, CEO of Samsung Bioepis
South Korea’s Samsung Bioepis announced Nov. 27 that Kyung-Ah Kim, PhD, has been appointed president and chief executive officer. Kim had been serving as executive vice president and development di...
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...
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...
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-...
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 ...
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...
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 ...
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...
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....
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 ...
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...
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...
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...
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 ...
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...
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...
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...
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...
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...
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...
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...
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’...
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 ...
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...
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...
Emerging Companies Pursuing Ophthalmic Indications, December 2023
Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.
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...
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...
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 ...
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...
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