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Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast® updates below.

2022

Pearce IP BioBlast®: w/e 14 January 2021

January 17, 2022

10 Jan 22 | CA | Alvotech and JAMP Pharma announced that Health Canada has approved Simlandi (high-concentration, citrate-free biosimilar adalimumab).

11 Jan 22 | EU | Orion Corporation and CuraTeQ Biologics announced an expansion to their biosimilar distribution agreement in Europe to include the Baltic countries.  All products under the agreement are still in development or regulatory phases, with launches estimated to take place in 2023-2026.

12 Jan 22 | The International Generics and Biosimilar Medicines Association (IGBA) announced the appointment of Vivian Fritelli as IGBA Chair for 2022.

14 Jan 22 | MoneyControl reported that Biocon is in the final stages of announcing the deal to buy Mylan’s biosimilar business.  In December 2021 MoneyControl reported that Biocon and Mylan were in advanced talks for the creation of a biosimilars spin-off, however neither party has confirmed this speculation.

Pearce IP offers Australian based, generics and biosimilars focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance.  Call us today on 02 9023 9988 or email info@pearceIP.law.

Pearce IP BioBlast®: w/e 07 January 2021

January 10, 2022

30 Dec 21 | US | Biocon Biologics announced that the US Court of Appeals for the Federal Circuit Court has upheld the US Patent and Trademark Appeal Board’s decisions of unpatentability for five device patents for Sanofi’s Lantus® (insulin glargine) SoloSTAR® as well as a district court decision on one of these patents.  Biocon and Viatris launched Semglee® (interchangeable biosimilar insulin glargine) in November 2021.

05 Jan 22 | US | Samsung Bioepis and Organon announced that the FDA has accepted for review the supplemental Biologics License Application for a citrate-free, high-concentration formulation of SB5 (biosimilar adalimumab).  Organon expects to launch this product in the US on or after 1 July 2023, in accordance with a licensing agreement with AbbVie.

05 Jan 22 | Amneal Pharmaceuticals and Saol Therapeutics announced that Amneal will acquire Saol’s Baclofen franchise.  This acquisition is expected to bolster Amneal’s commercial infrastructure in advance of its planned launches of biosimilar filgrastim, biosimilar pegfilgrastim and biosimilar bevacizumab in 2022.

07 Jan 22 | Coherus Biosciences announced that it has entered into a loan agreement with investment funds managed by Pharmakon Advisors, LP.   The agreement will provide Coherus with up to $300 million committed across four tranches.  The third and fourth tranches are conditional upon Coherus receiving approval of the BLA for its toripalimab and its biosimilar ranibizumab, respectively.

Pearce IP offers Australian based, generics and biosimilars focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance.  Call us today on 02 9023 9988 or email info@pearceIP.law.

Pearce IP BioBlast®: f/e 31 December 2021

January 4, 2022

20 Dec 21 | US | Sandoz announced that it has submitted a BLA to the FDA for a proposed biosimilar trastuzumab.

20 Dec 21 | US | The FDA approved Eli Lilly’s Rezvlogar® (biosimilar insulin glargine).

20 Dec 21 | US | Coherus announced that the FDA has approved Yusimry™ (biosimilar adalimumab).  Coherus plans to launch Yusimry™ in the US on or after 1 July 2023 in accordance with a 2019 agreement with AbbVie.

22 Dec 21 | EU | Sandoz announced that it has submitted a BLA to the EMA for a proposed biosimilar trastuzumab.

23 Dec 21 | Theramex and Enzene Biosciences announced that they have entered into an agreement for the development and commercialisation of biosimilar tocilizumab.  The product will be available in parenteral vials, PFS and autoinjectors from 2026 in Europe, the UK, Switzerland and Australia.

24 Dec 21 | CA | Health Canada approved Celltrion’s Yuflyma® (100mg/mL biosimilar adalimumab) for all indications as Humira®.

24 Dec 21 | CN | Innovent Biologics announced that China’s NMPA has accepted the supplemental New Drug Application for sintilimab plus biosimilar bevacizumab injection and chemotherapy in patients with EGFR-mutated non-squamous non-small cell lung-cancer who progressed after EGFR-TKI therapy.

Pearce IP offers Australian based, generics and biosimilars focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance.  Call us today on 02 9023 9988 or email info@pearceIP.law.

2021

Pearce IP BioBlast®: w/e 17 December 2021

December 21, 2021

11 Dec 21 | Samsung Bioepis announced that SB12 (proposed eculizumab biosimilar) met all the endpoints in a Ph I study.

13 Dec 21 | Xbrane Biopharma announced it is developing two new biosimilar candidates referencing Keytruda® (pembrolizumab) and Darzalex® (daratumumab).

14 Dec 21 | Hyphens Pharma announced that it has signed an exclusive license and supply agreement with DKSH’s subsidiary Favorex Pte Ltd for the commercialisation of Alvotech’s proposed biosimilar ustekinumab in Singapore, Malaysia and the Philippines.

17 Dec 21 | EU | Alvotech announced that the EC has approved AVT02 (100mg/mL biosimilar adalimumab), following the positive recommendation made by the CHMP in September 2021.

17 Dec 21 | US | AbbVie filed a complaint with the US International Trade Commission in relation to Alvotech’s AVT02, alleging the misuse of trade secrets.  The US District Court dismissed the trade secrets lawsuit brought by AbbVie against Alvotech also relating to AVT02 in October 2021.

Pearce IP offers Australian based, generics and biosimilars focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance.  Call us today on 02 9023 9988 or email info@pearceIP.law.

Pearce IP BioBlast®: w/e 10 December 2021

December 13, 2021

06 Dec 21 | AU | Australia’s TGA provisionally approved Celltrion’s Regkirona® (regdanvimab) for the treatment of adults with coronavirus who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19.

07 Dec 21 | Alvotech and Oaktree Acquisition Corp. II announced that they have entered into a merger agreement for the creation of a publicly-traded global biopharmaceutical company. Alvotech is led by a team of highly experienced biopharma leaders, including Mark Levick as CEO, Anil Okay as CCO, and Philip Caramanica as Chief IP Counsel and Deputy General Counsel. The merger is expected to deliver gross proceeds to Alvotech in excess of USD$450 million.  Alvotech currently has seven products in its pipeline, including a biosimilar candidate to Humira® (adalimumab), Stelara® (ustekinumab), Eylea® (aflibercept), Prolia®/Xgeva® (denosumab) and Simponi®/Simponi ARIA® (golimumab).

07  Dec 21 | Prestige BioPharma announced that its Ph I study of PBP1502 (proposed adalimumab biosimilar) has been registered with the US National Institute of Health.  Prestige disclosed that it plans to file marketing authorisation applications with the EMA and FDA in 2023.

08 Dec 21 | Samsung Bioepis announced that its Ontruzant® (biosimilar trastuzumab) demonstrated comparable long-term survival results with reference trastuzumab in five-year follow-up results.

09 Dec 21 | MoneyControl reported that Biocon and Mylan are in advanced talks for the creation of a biosimilars spin-off. To date neither party has confirmed these this speculation.

09 Dec 21 | US | Hikma Pharmaceuticals and Gedeon Richter announced that they have entered into an exclusive license agreement to commercialise Gedeon Richter’s proposed denosumab biosimilar in the United States.

09 Dec 21 | Dr Reddy’s and Prestige BioPharma announced that they have entered into an exclusive partnership for the supply and commercialisation of Prestige BioPharma’s proposed trastuzumab biosimilar in select countries in Latin America and Southeast Asia.

10 Dec 21 | Novartis CEO Vas Narasimhan announced that the potential sale of Sandoz has attracted interest from potential buyers.  Novartis is expected to decide the future of Sandoz by the end of 2022.

Pearce IP offers Australian based, generics and biosimilars focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance.  Call us today on 02 9023 9988 or email info@pearceIP.law.

Pearce IP BioBlast®: w/e 03 December 2021

December 6, 2021

01 Dec 21 | CN | Tot Biopharm announced that China’s NMPA has approved Pusintin® (biosimilar bevacizumab) for the treatment of patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer and patients with metastatic colorectal cancer.

01 Dec 21 | CA | British Columbia announced that it has expanded its biosimilar program to include insulin.  About 30,000 patients will now have six months to transition to Admelog® (biosimilar insulin lispro) and Trurapi® (biosimilar insulin aspart).

03 Dec 21 | BR | Lupin and Biomm announced that they have entered into an exclusive distribution and marketing agreement for biosimilar pegfilgrastim in Brazil.

03 Dec 21 | CN | Shanghai Henlius Biotech announced that China’s NMPA has approved Hanbeitai® (biosimilar bevacizumab) for the treatment of metastatic colorectal cancer and unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer.

Pearce IP offers Australian based, generics and biosimilars focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance.  Call us today on 02 9023 9988 or email info@pearceIP.law.