Search Results for “biosimilar ” – Page 4 – media

J&J signs Stelara biosimilar settlement deal with Formycon and Fresenius

Johnson & Johnson (J&J) has reached a settlement with Formycon and Fresenius over their Stelara biosimilar FYB202, setting its US launch date to 15 April 2025. The companies confirmed that they are on track to submit the biosimilar’s biologics license application (BLA) later this year, based on the 7 August announcement. This marks the third settlement reached by J&J and pharma companies that are trying to market Stelara’s biosimilars this year so far. In May, J&J settled its patent lawsuit with Amgen, setting the biosimilar’s launch to no later than 1 January 2025. A month later, J&J reached a settlement with the producers Alvotech and Teva Pharmaceuticals, with a US licence entry date for their Stelara biosimilar AVT04 of no later than 21 February 2025. Also known as ustekinumab, Stelara was first approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with moderate to ...
- Source: drugdu
- 191
- August 10, 2023
Sandoz Granted Positive CHMP Opinion for Multiple Sclerosis Biosimilar

Sandoz, a Novartis division, has announced that its multiple sclerosis (MS) biosimilar has been recommended by the European Medicines Agency’s (EMA) human medicines committee as a single disease-modifying therapy in adults with highly active relapsing-remitting forms of the disease. The “first-of-a-kind” biosimilar natalizumab, developed by Polpharma Biologics, is a version of Tysabri (natalizumab). Biosimilars, according to the EMA, are biological products that are highly similar to a medicine already approved in the EU. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they could potentially lower healthcare costs. Pierre Bourdage, chief commercial officer, Sandoz, said: “Access to affordable, high-quality treatments like disease-modifying therapies – which are a cornerstone in the treatment of MS – remains limited for many people living with this disease.” Over 2.8 million people worldwide are affected by MS, a disabling and unpredictable ...
- Source: drugdu
- 123
- July 26, 2023
Sandoz Invests $90m to Build a Biosimilar Centre in Slovenia

Sandoz has invested $90m to build a biopharma development centre in Ljubljana, Slovenia by 2026. The site will serve to develop biosimilar products and is expected to create 200 new jobs. This follows Novartis’ financial report stating $2.4bn in net sales for Sandoz biosimilars in Q2 2023, along with the proposed 100% separation of Sandoz from Novartis to form an independent company by the end of this year. The fully independent Sandoz will be headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange and American Depositary Receipt (ADR) programme in the US, as per a 1 June press release. To that end, the development centre is the company’s second major investment in Slovenia. In March, the Novartis spin-off announced plans to construct a biologics production plant in Lendava, Slovenia, to support the increasing product demand. According to a press release, Sandoz chief ...
- Source: drugdu
- 110
- July 24, 2023
Sandoz doubles down on biosimilars with $90M Slovenia site where it plans to hire 200

Sandoz is doubling down on its commitment to Slovenia in its globe-trotting biosimilar growth quest.The Novartis generics unit is plugging $90 million into a new biosimilar technical development center in Ljubljana, Slovenia, where the company aims to hire 200 new staffers. The new site, which Sandoz says will become “key” to its biosimilar development, will feature end-to-end drug substance and drug product development, the company said in a press release Thursday. This isn’t Sandoz’s first foray into the Balkan country. The announcement follows the company’s recent plan to invest a whopping $400 million in a new manufacturing plant there in Lendava. What’s more, Sandoz has already set up prior complex generic development capabilities in Ljubljana. Nearby, the company is also expanding its biosimilar development firepower in Holzkirchen, Germany. The latest move comes shortly after Sandoz unveiled its Act4Biosimilars action plan in June, under which it’s angling to triple global biosim ...
- Source: drugdu
- 118
- July 22, 2023
Sandoz launches high-concentration biosimilar of AbbVie’s Humira in the US

Sandoz, a Novartis division, has announced the US launch of its citrate-free high-concentration formulation (HCF) of Hyrimoz (adalimumab-adaz) – a biosimilar version of AbbVie’s Humira (adalimumab). Hyrimoz HCF (100mg/mL) is approved to treat all indications that are no longer covered by the reference medicine regulatory exclusivity, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. Biosimilars, according to the US Food and Drug Administration (FDA), are biological products that are highly similar to an existing FDA-approved reference product. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they potentially lower healthcare costs. Hyrimoz was approved by the FDA in 2018 at a concentration of 50mg/mL. The HCF offers a 50% reduction compared to the original concentration and can decrease the number of injections required for people who need at least 80mg ...
- Source: drugdu
- 116
- July 7, 2023
first interchangeable biosimilar to Humira rolls out across US

Boehringer Ingelheim’s new autoinjector pen administering Cyltezo (adalimumab-adbm) is now available to patients living with chronic inflammatory diseases in the US. The Cyltezo pen autoinjector, which is a biosimilar to AbbVie’s blockbuster Humira (adalimumab), received approval from the US Food and Drug Administration (FDA) in May 2023. Boehringer Ingelheim originally received FDA approval for the drug in 2017, and then further approval as an interchangeable biosimilar in 2021. The 40mg/0.8ml pre-filled Cyltezo Pen will be offered in two, four and six-pack options. AbbVie has enjoyed a prosperous monopoly of the adalimumab market with Humira generating $21.2bn in global sales in 2022. With several biosimilars likely to flood the market in 2023 and the company losing exclusivity, AbbVie said it expects its sales of the drug to decline 37% in 2023. Challengers to Humira are now vying for market share. Organon and Samsung Bioepsis launched an autoinjector pen on 1 July, ...
- Source: drugdu
- 133
- July 5, 2023
FDA rejects Alvotech’s Humira biosimilar for the third time

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Humira biosimilar AVT02, further delaying the company’s plans to launch the drug in a landmark year. The agency rejected the drug’s biologics licence application (BLA) over deficiencies seen at one of the company’s manufacturing facilities in Reykjavik, Iceland, according to Alvotech’s press release on 28 June. While the FDA did not make a note of any other deficiencies in the BLA, issues related to the Reykjavik facility need to be resolved to facilitate the drug’s potential approval. This marks the second time that the FDA has rejected AVT02’s BLA this year. In April, the regulator issued a CRL to Alvotech, which also noted the deficiencies seen in the company’s Reykjavik plant. Prior to that, the company received a CRL from the FDA over deficiencies in the plant in September 2022. Alvotech plans to resubmit ...
- Source: drugdu
- 108
- July 1, 2023
Samsung Biologics, Pfizer partner for biosimilars portfolio manufacturing

Samsung Biologics has announced a strategic collaboration with Pfizer for the long-term commercial manufacturing of the latter’s multi-product biosimilars portfolio. Initially, the companies signed a manufacturing agreement in March last year for a Pfizer product. As per the new agreement terms, Samsung Biologics will provide Pfizer with more capacity for manufacturing for the biosimilars portfolio. The portfolio will cover inflammation, oncology and immunology. Samsung will use its new facility, Plant 4, for the products manufacturing. Samsung Biologics president and CEO John Rim said: “We are pleased to extend the strategic collaboration with Pfizer as we share and support their strong vision to bring innovative solutions for patients around the globe. “This new meaningful partnership comes just as our Plant 4 is fully completed early this month as we had previously committed and are on the move for future expansion into our second campus in order to provide our clients with ...
- Source: drugdu
- 114
- June 12, 2023
Pfizer taps Samsung Biologics in long-term biosimilar production deal worth $411M

South Korea’s Samsung Biologics has captured a $411 million contract to manufacture biosimilars for pharma giant Pfizer.Under the deal, Samsung has pledged “additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio covering oncology, inflammation, and immunology.” The company described the deal as a “long-term” arrangement. Pfizer’s biosimilar portfolio features copycats to Roche’s cancer trio of Rituxan, Avastin and Herceptin plus biosimilar versions of Johnson & Johnson’s Remicade and Amgen’s Neupogen. The Samsung partnership will likely also include production of Pfizer’s biosimilar to AbbVie’s Humira, The Korea Herald reports, citing industry experts. AbbVie recorded $21.24 billion in sales of Humira last year. Amgen is already marketing a Humira copycat, but Pfizer and many other players are set to enter the market this year. In a financial filing, Samsung Biologics put the value of the Pfizer deal at $411 million, making it the biggest of its nature for the company and ...
- Source: drugdu
- 117
- June 11, 2023
Biosimilars ‘Fulfilling Their Promise’ of Lowering Biologic Prices

By Tristan Manalac Pictured: Cancer patient in bed looking out window / iStock, Ridofranz The entry of biosimilars promotes healthy market competition. It can reduce the prices of branded biologic medicines, according to a new study from the University of Southern California’s Leonard D. Schaeffer Center for Health Policy & Economics. The study, published online Tuesday in the journal Health Affairs, focused on Genentech’s (Roche) breast cancer treatment Herceptin (trastuzumab) and its five biosimilar competitors that entered the U.S. market starting in 2019: Amgen’s Kanjinti, Viatris’ Ogivri, Pfizer’s Trazimera, Teva’s Herzuma and Organon’s Ontruzant. Study results showed that when Herceptin’s first biosimilar competitor—Kanjinti—hit the market, its average price dropped around 21%, from $101 to $80 per 10 mg. By the second quarter of 2022, toward the end of the study’s analysis period, biosimilars maintained an average sales price of 28% to 58% of Herceptin’s pre-competition average sales price. “Trastuzumab is ...
- Source: drugdu
- 200
- June 9, 2023

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