Biosimilar

Implications of Biosimilar Availability in the United States' Ophthalmology Markets Highlighted in New Spherix Global Insights Study

Retrieved on: 
Tuesday, January 10, 2023
Education, CME, Ophthalmology, Research, Knowledge, Samsung, Learning, Regeneron Pharmaceuticals, Pressure, Safety, FDA, Biosimilar, Lupinus, Celltrion, Retina, Sequential high-dose chemotherapy, Generic drug, Genentech, Ranibizumab, Biogen, Novartis

EXTON, Pa., Jan. 10, 2023 /PRNewswire/ -- Ophthalmologists saw the entry of the first biosimilars into the armamentarium in 2022 with the launch of Biogen and Samsung's Byooviz and Coherus Bioscience's Cimerli (both biosimilars to Genentech's Lucentis). But are they being used?

Key Points: 
  • According to the December 2022 Spherix report, while access has opened to biosimilars in ophthalmology since last wave (fielded November 2021) comfort and familiarity ratings with the class has gone down.
  • There is minimal familiarity with the pipeline biosimilar manufacturers Biogen, Bausch, Amgen, Samsung, Sandoz, Coherus Biosciences, Lupin, Alvotech, Celltrion, Xbrane, and Formycon.
  • Though ophthalmologists have now had access to an FDA approved biosimilar for half a year, the future of biosimilars in ophthalmology remains uncertain.
  • Continued education and financial incentives will become essential if biosimilars are to become a mainstay in ophthalmological markets.

Rani Therapeutics Receives Feedback from Pre-IND Meeting with FDA; Provides Pipeline Update

Retrieved on: 
Thursday, January 5, 2023
Ustekinumab, PTH, Part, Food, Therapy, Drug discovery, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Osteoporosis, SAN, Initiation, Safety, Feedback, FDA, Biosimilar, IND, Psoriasis, Ulcerative colitis, Pharmaceutical industry

SAN JOSE, Calif., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced that it completed a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (“FDA”) with respect to RT-102, the RaniPill™ GO containing a proprietary formulation of human parathyroid hormone (1-34) analog (PTH) for the potential treatment of osteoporosis, and provided a corporate update.

Key Points: 
  • Preliminary feedback received from the FDA on future development of RT-102.
  • Following feedback from a pre-IND meeting with the FDA, Rani believes that a 505(b)(2) pathway is suitable for the development of RT-102 in the U.S.
  • In December 2022, Rani announced positive topline results from Part 2 (repeat-dose portion) of the Phase 1 study of RT-102.
  • Rani Therapeutics is a clinical-stage biotherapeutics company focused on advancing technologies to enable the development of orally administered biologics and drugs.

Replimune Appoints Former Sanofi U.S. Commercial Oncology Head, Chris Sarchi, as Chief Commercial Officer and Sushil Patel as Chief Strategy Officer

Retrieved on: 
Wednesday, January 4, 2023
Hoffmann-La Roche, IMS Health, Boehringer Ingelheim, Head, Genentech, University of London, Squamous cell carcinoma, RP1, RP2, Health, GSK, Skin, CSCC, RP3, University, Imperial College London, Center for Study of Science, Technology and Policy (CSTEP), Nursing, BCC, Marketing, Molecular biology, Management, Fine chemical, Sanofi, Biotechnology, Science, Medicine, Vismodegib, Biosimilar

“These leadership appointments provide broad strategic and operational commercial acumen as we ramp up our commercial planning ahead of the potential 2024 commercial launch of RP1,” said Philip Astley-Sparke, Chief Executive Officer of Replimune.

Key Points: 
  • “These leadership appointments provide broad strategic and operational commercial acumen as we ramp up our commercial planning ahead of the potential 2024 commercial launch of RP1,” said Philip Astley-Sparke, Chief Executive Officer of Replimune.
  • “Chris led the launch of Libtayo in cutaneous squamous cell carcinoma (CSCC) at Sanofi, and was also involved with the launch of Erivedge in basal cell carcinoma (BCC) when at Genentech.
  • Sush will partner with Chris on our go-to-market strategy in the U.S. with RP1 and also in defining our commercialization strategy for the rest of the world.
  • Chris began his career with GSK where he held several sales and marketing leadership roles of increasing responsibility.

Sandoz Canada supports Ontario policy change to cover biosimilars which will generate significant cost savings and improve patient access to quality medicines

Retrieved on: 
Thursday, December 22, 2022
Health Canada, Ontario government debt, Health, Customer engagement, Adalimumab, Patient, Policy, Support, Biosimilar, Safety, Novartis, Health insurance, Generic drug

Biosimilar switch policies are an important step towards increasing patient access to quality and potentially life-enhancing biosimilar medicines while realizing significant health system cost savings.

Key Points: 
  • Biosimilar switch policies are an important step towards increasing patient access to quality and potentially life-enhancing biosimilar medicines while realizing significant health system cost savings.
  • Sandoz Canada is committed to supporting patients, their healthcare professionals, and the Ontario Government with quality biosimilar medicines and experienced, comprehensive patient support programs.
  • “Biosimilar switch policies are an important step towards increasing patient access to quality and potentially life-enhancing biosimilar medicines they need while realizing significant health system cost savings.
  • Above all, Sandoz Canada has one of the leading Biosimilar Patient Support Program in Canada with over 20,000 patients.

Update on U.S. Regulatory Status of AVT02, Alvotech’s Proposed High-Concentration, Interchangeable Biosimilar to Humira®

Retrieved on: 
Thursday, December 22, 2022
TASE, Endpoint security, Food, BLA, Patient, NYSE, Teva Pharmaceuticals, FDA, Biosimilar, Food and Drug Administration, TEVA, Marketing, Generic drug, Dietary supplement

Approval of the application requires satisfactory outcome of a reinspection of Alvotech’s facility in Reykjavik, Iceland.

Key Points: 
  • Approval of the application requires satisfactory outcome of a reinspection of Alvotech’s facility in Reykjavik, Iceland.
  • Alvotech is working with the FDA to schedule a reinspection in the first quarter of 2023.
  • The key requirement for approval is the same as for the original BLA, which is a satisfactory outcome of the facility reinspection.
  • AVT02 has been launched in 17 markets around the world, including Canada, Germany, and France and has received marketing approval in 35 countries.

Correction to Total Amount in Announcement About Private Placement Published 2022-12-16 09:00 GMT to headline field

Retrieved on: 
Friday, December 16, 2022
Osteoporosis, Stada Arzneimittel, PIK, Communication, Partnership, Marketing, Offering, Degenerative disease, Sale, Cancer, DKSH, ISK, USD, Biosimilar, Teva Pharmaceuticals, Respiratory disease, COVID-19, Patient, Security (finance), EU, Bond, Alvogen

REYKJAVIK, Iceland, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced completion of a private placement of approximately US$70 million, at current exchange rates, of subordinated convertible bonds (the “Bonds”), which consists of two tranches, Tranche A and Tranche B, convertible into new fully paid ordinary shares of Alvotech.

Key Points: 
  • Reference is made to the announcement issued earlier today about the completion of a private placement of subordinated convertible bonds.
  • Alvotech intends to use the majority of the net proceeds from the private placement offering to replace a US$50 million unsecured subordinated loan from Alvogen (“Alvogen Facility”) which was announced on November 16, 2022 .
  • In accordance with the Alvogen Facility agreement, associated rights by Alvogen to procure warrants representing up to 4.0% of Alvotech’s ordinary share capital will no longer apply.
  • Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended.

Alvotech Completes $59.7 Million Private Placement

Retrieved on: 
Friday, December 16, 2022
Osteoporosis, Stada Arzneimittel, PIK, Communication, Partnership, Marketing, Offering, Degenerative disease, Sale, Cancer, DKSH, ISK, USD, Biosimilar, Teva Pharmaceuticals, Respiratory disease, COVID-19, Patient, Security (finance), EU, Bond, Alvogen

REYKJAVIK, Iceland, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced completion of a private placement of approximately US$59.7 million, at current exchange rates, of subordinated convertible bonds (the “Bonds”), convertible into new fully paid ordinary shares of Alvotech.

Key Points: 
  • REYKJAVIK, Iceland, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced completion of a private placement of approximately US$59.7 million, at current exchange rates, of subordinated convertible bonds (the “Bonds”), convertible into new fully paid ordinary shares of Alvotech.
  • Alvotech intends to use the majority of the net proceeds from the private placement offering to replace a US$50 million unsecured subordinated loan from Alvogen (“Alvogen Facility”) which was announced on November 16, 2022 .
  • Alvotech will issue the Bonds in an aggregate principal amount of approximately US$59.7 million, at today’s exchange rate, in the form of subordinated convertible bonds, with a maturity of 36 months and in two tranches.
  • Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide.

Alvotech Completes $59.7 Million Private Placement

Retrieved on: 
Friday, December 16, 2022
Osteoporosis, Stada Arzneimittel, PIK, Communication, Partnership, Marketing, Offering, Degenerative disease, Sale, Cancer, DKSH, ISK, USD, Biosimilar, Teva Pharmaceuticals, Respiratory disease, COVID-19, Patient, Security (finance), EU, Bond, Alvogen

REYKJAVIK, Iceland, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced completion of a private placement of approximately US$59.7 million, at current exchange rates, of subordinated convertible bonds (the “Bonds”), convertible into new fully paid ordinary shares of Alvotech.

Key Points: 
  • REYKJAVIK, Iceland, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced completion of a private placement of approximately US$59.7 million, at current exchange rates, of subordinated convertible bonds (the “Bonds”), convertible into new fully paid ordinary shares of Alvotech.
  • Alvotech intends to use the majority of the net proceeds from the private placement offering to replace a US$50 million unsecured subordinated loan from Alvogen (“Alvogen Facility”) which was announced on November 16, 2022 .
  • Alvotech will issue the Bonds in an aggregate principal amount of approximately US$59.7 million, at today’s exchange rate, in the form of subordinated convertible bonds, with a maturity of 36 months and in two tranches.
  • Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide.

Vincerx Pharma Presents Preclinical Data on VIP943 in Acute Myeloid Leukemia Models at the 64th American Society of Hematology Annual Meeting 2022

Retrieved on: 
Sunday, December 11, 2022
Enzyme, Flow cytometry, WBC, Primate, ASH, AML, Hematocrit, Toxicity, COVID-19, Basophil, Observation, Bilirubin, Form 10-K, Gemstone, NHP, Reticulocyte, Safety, Cancer, Antibody-drug conjugate, CD123, Workforce, Biosimilar, Society, Pandemic, Hematology, Therapy, Diffusion, ADC, Control, Venetoclax, Male, PALO, Patient, Azacitidine, Failure, Bone marrow, Myelocyte, 8-K, Toxic shock syndrome, Drug Quality and Security Act, Survival, Lymphocyte, IND, KSPI, Fine chemical, Pharmaceutical industry, Risk management, Gemtuzumab ozogamicin, Bayer

PALO ALTO, Calif., Dec. 11, 2022 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today announced a poster presentation of preclinical data of Vincerx’s proprietary payload and linker technology and VIP943, the Company’s internalizing ADC targeting CD123, at the 64th American Society of Hematology (ASH) Annual Meeting 2022.

Key Points: 
  • VIP943 combines the unique payload class of kinesin spindle protein inhibitors (KSPi) with a proprietary legumain-cleavable linker.
  • “I am truly excited about the preclinical results for VIP943 and our proprietary payload and linker technology presented at ASH,” said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx.
  • The in vivo AML mouse model results also showed improved efficacy and survival for VIP943 in combination with venetoclax and azacitidine.
  • Forward-looking statements speak only as of the date hereof, and Vincerx disclaims any obligation to update any forward-looking statements.

Alvotech Shares Start Trading on Nasdaq Iceland Main Market

Retrieved on: 
Thursday, December 8, 2022
Osteoporosis, Marketing, Sale, Post Office Passport Seva Kendra, DKSH, Main–Market Historic District, COVID-19, Stada Arzneimittel, Cancer, Nasdaq Iceland, Main, Biosimilar, Nasdaq First North, Degenerative disease, Prospectus, Respiratory disease, Patient, Communication, Teva Pharmaceuticals, Partnership, EU

Robert Wessman Founder and Executive Chairman will ring the Nasdaq Iceland closing bell at 15:30 GMT on December 8, 2022

Key Points: 
  • Robert Wessman Founder and Executive Chairman will ring the Nasdaq Iceland closing bell at 15:30 GMT on December 8, 2022
    Listing on the Main Market can increase visibility, which may allow the company to appear in both domestic and global indexes
    Alvotech became first dual-listed Icelandic company in the U.S. and Iceland after market debut in June, trading under the symbol “ALVO“
    REYKJAVIK, Iceland, Dec. 08, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced that trading in its shares will move from the Nasdaq Iceland First North Growth market (“First North”) to the Nasdaq Iceland Main Market (“Main Market”), starting today December 8, 2022.
  • The “ALVO” stock market symbol for Alvotech remains unchanged and trade on the Nasdaq U.S. stock exchange is not affected.  A Main Market listing in Iceland can increase a company’s visibility and, subject to meeting certain conditions, may result in inclusion in Icelandic and international indexes.
  • Alvotech’s shares have been dual listed since June 2022, after being admitted to trading the Nasdaq Stock Market in the U.S. on June 16, 2022 and on First North on June 23, 2022 .
  • On August 12, 2022 , Alvotech’s Board of Directors announced a plan to move the listing from First North to the Main Market and on December 2, 2022 Nasdaq Iceland approved Alvotech’s request to trade its shares on the Main Market.