FORMYCON WKN: A1EWVY ISIN: DE000A1EWVY8 Kürzel: FYB Forum: Aktien Thema: Hauptdiskussion

Leider ja, einfach nicht mehr reingucken...

Das hier ist ein Gemetzel, wahnsinn.

Die Aktien werden auch alle zum Sonderangebot rausgehauen 😅

Weiterhin ein klarer Kauf 👌

Yes, that’s a very fair question. The additional manufacturing work required, that the FDA wanted to see as far as the movement of this piece of equipment as we indicated earlier is like four months worth of work. And as soon as we schedule that and wrap that up, we can go ahead and get the file resubmitted. We don’t have guidance for you right now, as to exactly how fast that can get the schedule. We are scheduling that sort of as we speak. And so, it’s difficult to address your question in terms of when do we think. I would say that, we believe that we will get that file resubmitted certainly within 2020, which should get it approved in 2021. But I don’t have any further granularity for you fortunately at this time in terms of actual timing, so I would tell you.

I'd like to get your idea on the biosimilar Lucentis launch, because I know that one of the key advantages of that in-license was that it basically moves you guys up to the front position. So, I’d like to see what’s the delay? Are you still projecting that you're going to be the first biosimilar on the market?

hat’s a great question, Doug. I think that it’s fair to say that we like the synergy that we are currently pursing with having in-licensed products in tandem with internally developed products. I think a prime example of that is Lucentis biosimilar hand-in-hand with Eylea biosimilar. It balances the launch timing. It balances for example, the economic alignment issues and so on. Similarly, with UDENYCA, wholly-owned products, strong in the oncology space and so we feel comfortable adding additional oncology products that are in-licensed that may not have all the same sorts of margins due to licensing fees. We think that the return on investment for internally – for externally brought in products is very high. And we also feel that leveraging the commercial footprint both in terms of oncology and ophthalmology, is very wise, as we said further to the overall strategy of the company. So, we look at it very much and that sort of balance. Biosimilars are perhaps the $150 million per product to develop. So, you probably don’t want to take all that risk with every single product. However in these therapeutic areas, you’ll certainly have at least one product if not products that you develop yourself internally. Is that helpful?

Eylea ist bestimmt auch unseres :)

Von Coherus und für viele evtl. very interesting...hoffe jeder beherrscht Englisch et me first discuss the company's ophthalmology franchise. With respect to our Lucentis biosimilar in-licensed from Bioeq, we are currently focused on supporting our partner to generate the additional manufacturing data as requested by FDA and expect to resubmit the application upon completion of these efforts and certain regulatory interactions. With respect to our CHS-2020 Eylea biosimilar, we are very pleased with our progress and are now in position to initiate commercial scale, GMP manufacturing efforts in support of the expected Phase III clinical trials in 2021 with launch projected in 2025. As we have previously discussed, these products will compete in $6 billion anti-VEGF U.S. market with favorable order of entry and competitive dynamics. Ophthalmology is reimbursed under the buy-and-bill model, a reimbursement dynamic in which we have demonstrated proficiency and biosimilar market conversion, delivering greater patient access and healthcare system savings.

Formycon kann ein paar Milliarden Wert wersen

Ich kaufe bei 20 wieder.

Börse Online bewertet Formycon in der aktuellen Ausgabe als potenziellen Übernahmekandidaten. HohesRisiko durch Zulassungsrisiko mit Kursziel 40

1300! Dako, nachlegen ja. Meiner Meinung nach in Tranchen da nicht klar ist was hier noch die nächsten Wochen passiert. Viel Erfolg

Ihr legt also nach??? Ich binnnoch am überlegen.

Die wird aber noch kommen

Keine Nachfrage da.