1. What is the Chemxpert database?

Chemxpert database is a techno-commercial information platform developed and operated by Lifescience Intellipedia Pvt. Ltd. Our data provides valuable insights regarding sourcing, marketing, development, and regulatory functions for the entire Lifescience industry. The different industries covered by our data encompass APIs, FDFs, pharma intermediates, paints, dyes, polymers, biotechnology, biochemical, food additives, nutraceuticals, etc.

2. How can I subscribe to the Chemxpert database?

You can gain access to the Chemxpert database after subscribing to it by visiting this link: - https://chemxpert.com/pricing

3. How many countries' data is available on your portal?

The Chemxpert database covers more than 200 countries. We are working in the direction of expanding our data coverage in more countries.

4. What are the different sources you use for obtaining information?

The different sources we use for data collection are as follows: - • Primary researc • DMF, ANDA, & CEP list • Conferences, Exhibitions, & Tradeshow • Company annual reports • DMF, ANDA, & CEP list • Subject matter experts & KOL survey. Apart from these, our other valuable sources include application-wise manufacturers list, subscribed and non-subscribed databases, corporate partners, US FDA Orange book, publicly available sources, industry associates, national statistics, regulatory websites, etc. You can gain access to the Chemxpert database after subscribing to it by visiting this link: -https://chemxpert.com/sources

5. What is the expected time for account activation?

Your Chemxpert account will be activated instantly if the payment is made through our website. If you choose to use RTGS, NEFT, or IMPS systems for payment, your account will be activated within 24 hours.

25 Jun 2025
Admin
News Article

EMA committee recommends marketing approval of AVT06, Alvotech’s proposed biosimilar to Eylea

Overview

Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) adopted a positive opinion recommending approval for AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept 2 mg). Based on a positive recommendation by CHMP, biosimilar medicines can be approved by the European Commission for marketing in the European Economic Area, that includes the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein.

Statement from Joseph McClellan: Chief scientific officer of Alvotech

"CHMP’s positive opinion takes us a step closer to being able to market our proposed biosimilar in Europe, which is excellent news for patients and their caregivers. Alvotech looks forward to increasing access to this vital biologic treatment for eye disorders,"" said Joseph McClellan, chief scientific officer of Alvotech.

Statement from Nick Warwick: CMO of Advanz Pharma

“We are pleased with the CHMP’s positive opinion, which marks an important milestone in our mission to bring high-quality, specialist medicines to patients across Europe,” said Nick Warwick, chief medical officer of Advanz Pharma.

For marketing authorization

The CHMP opinion recommends granting of a marketing authorization for AVT06 intended for the treatment of adults with neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).

Alvotech for commercial & development supply

Alvotech is responsible for the development and commercial supply of the proposed biosimilar.
Advanz Pharma is responsible for registration and has exclusive commercialization rights for most countries in Europe.

In 2024, global sales of Eylea were about US$9 billion, and one third of these sales were in Europe.

AVT06 (AVT06-GL-C01) results

In January 2024 Alvotech announced positive top-line results from a confirmatory clinical study with AVT06 (AVT06-GL-C01) comparing the efficacy, safety, and immunogenicity of the proposed biosimilar to Eylea in patients with neovascular (wet) AMD.
The study met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech’s biosimilar candidate and Eylea.

Alvotech is also developing AVT29, a proposed biosimilar to Eylea HD, a higher dose (aflibercept 8 mg) aflibercept. Advanz has licensed the distribution rights from Alvotech for both biosimilar candidates, for the same territory.

The new recombinant fusion protein: AVT06

AVT06 is a recombinant fusion protein and a biosimilar candidate to Eylea (aflibercept), which binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability.
AVT06 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.

About the company: Alvotech

Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide.
Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities.

About Advanz Pharma

Partner of choice in specialty, hospital, and rare disease medicines.
Advanz Pharma is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on.

Let’s apply Data-Driven Pricing to Your APIs

Sick and tired of always wondering if you are being asked to pay the right price for your APIs? This empowers you with the answers you need to make the right decisions in the Global API market.

Chemxpert Database is one of the biggest and most comprehensive directories of pharma and chemicals, manufacturers, suppliers and information. Provided with current information on prices, demand and transactions, it gives you instant feedback on whether you are buying what is right and at the right time.

Start using market intelligence today and allow yourself to be in control in the API market.

Check it out today and make more informed sourcing decisions! Learn More!