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BioBlast f/e 16 Jun 23

by | Jun 19, 2023

BusinessWire reports that Bio-Thera Solutions and Biomm SA have reached a licensing and supply agreement for BAT2206 (ustekinumab biosimilar).  Under the agreement, Biomm will have exclusive rights to distribute and market the product in Brazil.

We previously reported that Bio-Thera has previously entered into a licence agreement with Hikma for the US (with option to add Europe) and with Pharmapark for Russia and other CIS countries.

The Economic Times in India reported that Glenmark provided a drastic price drop in India for Trumab® (trastuzumab), biosimilar to Genentech’s Herceptin®.  Glenmark reduced the cost of its 440mg vial from ₹54,000 down over 70% to ₹15,749 in a market supplying the medicine for between Rs 40,000 and Rs 50,000 per vial.

Genentech announced that the FDA approved Columvi® (glofitamab-gxbm) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.  The FDA approved Columvi® under the accelerated approval pathway based on a phase I/II clinical trial.  Genentech confirmed that Columvi® will be available in the US in the coming weeks.

On 26 April 2023, the EMA’s Committee for Medicinal Products for Human Use recommended approval of Columvi® for R/R DLBCL.

Sandoz announced its new Act4Biosmilars Action Plan as part of its Act4Biosimilars initiative that aims to increase the adoption of biosimilars in over 30 countries by 30% by 2030.  The Plan features 12 initiatives to help accelerate biosimilar uptake, examining accessibility, affordability, approvability and acceptability.

The Plan will be supported by reports analysing challenges for biosimilar uptake across jurisdictions.  Sandoz confirmed that it will first report on issues in the Americas, including the complex interchangeability guidelines in the US, the risk to patients in Colombia and Ecuador where biosimilars may not meet appropriate WHO guidelines, lack of consistency in educational materials across Canada, the US and Brazil, and supply chain risks in Mexico and Brazil.

The Act4Biosimilars Impact Index will measure and assess progress for 30 initiative-tracked countries in relation to the favourability of the local environment towards biosimilars.

Sandoz initially launched its Act4Biosimilars campaign in May 2022.

Coherus has confirmed in a Form 8-K filed with the SEC that it has resolved its recent dispute with AbbVie relating to a potential breach of its settlement and licence agreement entered into in late 2019, under which Coherus received a royalty bearing non-exclusive licence to commercialise its biosimilar adalimumab YUSIMRY® from 1 July 2023.

According to the SEC disclosure, in a letter from AbbVie Coherus received on 6 June 2023, AbbVie claimed that Coherus breached its obligations under the agreement by announcing an 85% discount for its US launch of YUSIMRY® and its partnership with Mark Cuban on 1 June 2023.

Coherus responded to AbbVie on 11 June 2023 denying the allegation and requesting more information. On 13 June, it also filed a motion for a temporary restraining order in the District Court of Delaware against AbbVie to prevent it from terminating the license, and AbbVie filed for preliminary injunction on the same day

After negotiations the next day, 14 June 2023, Coherus agreed to resolve its motion for a temporary restraining order against AbbVie, and AbbVie agreed not to terminate the licence agreement relating to the commercialisation of YUSIMRY®, adalimumab biosimilar to AbbVie’s Humira®.  AbbVie will only be entitled to terminate if it serves a new notice of breach and affords Coherus an opportunity to cure any alleged breach.

Seagen’s SEC filing has disclosed that Pfizer withdrew its notification to the Federal Trade Commission (FTC) and Department of Justice (DOJ) to acquire Seagen for US$43B.  The filing also notes that the companies expect to complete the acquisition in late 2023 or early 2024.

On 12 March 2023, Seagen and Pfizer entered into an agreement to merge, in which Seagen would become a wholly-owned subsidiary of Pfizer.  On 12 May 2023, Seagen and Pfizer each filed a Notification and Report Form relating to the merger with the FTC and DOJ as required under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (Act). Only a few days later, the FTC brought proceedings to block Amgen’s US$27.8B acquisition of Horizon Therapeutics.  On 30 May 2023, Seagen shareholders approved the acquisition by Pfizer.

By withdrawing the form, the statutory waiting period under the Act will now expire on 14 July 2023 (which can be extended if the FTC requests additional information / documents).  Whilst it is possible that Pfizer’s notification withdrawal is in response to FTC proceedings against Amgen, it has not yet been confirmed by either Pfizer or Seagen.

Pfizer also filed the requisite documentation with the European Commission pursuant to Article 4(5) of the EU Merger Regulation, alerting it of the intended merger on 1 June 2023.

The Korea Economic Daily reports that Celltrion announced it intends to apply for regulatory approval of five new biosimilars before the end of 2023. Celltrion intends to offer more than 10 biosimilars by 2025, of which it currently offers six.  Celltrion also confirmed that its biosimilar to Amgen’s Prolia® (denosumab) and Genentech’s Actemra® (tocilizumab) are in phase III clinical trials and it intends to apply for their approval by the end of 2023.

Since April 2023, Celltrion has filed MAAs with the EMA for its biosimilar to Janssen’s Stelara® (ustekinumab) and its biosimilar to Genentech/Novartis’ Xolair® (omalizumab), has submitted a phase III IND plan to the FDA for its biosimilar to Genentech’s Ocrevus® (ocrelizumab), and announced positive phase III trials for its biosimilar to Regeneron’s Eylea® (aflibercept).

AstraZeneca announced that the Chinese NMPA has approved Soliris® (eculizumab) for treatment of refractory generalised myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. This is the third approved indication approved for Soliris® in China, and is the first and only complement inhibitor approved to treat gMG in China.  The NMPA’s approval was based on results of the Phase III REGAIN trial in which Soliris® demonstrated clinical benefit for patients with anti-AChR antibody-positive gMG who had previously failed immunosuppressive treatment and suffered significant unresolved disease symptoms.

Biosimilars to Soliris® are in the pipeline: on 30 May 2023 Samsung Bioepis’ Epysqli® (eculizumab) was approved in Europe to treat paroxysmal nocturnal hemoglobinuria, and on 23 February 2023 the CHMP recommended MA for Amgen’s Bekemv® for the same condition.

Alvotech and Teva announced they have reached a settlement and license agreement with Johnson & Johnson for AVT04, Alvotech’s biosimilar to Stelara® (ustekinumab).  J&J have granted a license entry date for AVT04 in the US no later than 21 February 2025. This is seven weeks after the reported date by which Amgen will be able to enter the market (1 January 2025) pursuant to its recent settlement with J&J.

On 6 January 2023, the FDA accepted the BLA for AVT04.

Biogen announced that the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) unanimously voted that the results of a specific Eisai phase III clinical trial verified the clinical benefit of LEQEMBI® (lecanemab) for the treatment of Alzheimer’s disease.  The Committee also confirmed the overall benefit-risk profile and the clinical meaningfulness of the data.  The FDA released a briefing document on 7 June 2023 outlining its views ahead of the PCNS meeting on 9 June 2023.

On 5 March 2023, Biogen and Eisai Co announced that the FDA has accepted their sBLA and granted priority review for traditional approval of LEQEMBI™ (lecanemab) for treatment of Alzheimer’s disease.  It was approved under the Accelerated Approval Pathway on 6 January 2023 (approval based on ‘surrogate’ marker or endpoint).

JAMA Ophthalmology published the results of Ph III trials of Samsung Bioepis’ SB15 (aflibercept biosimilar).  Researchers reported that SB15 showed equivalent efficacy and comparable safety, pharmacokinetics and immunogenicity to reference aflibercept in participants with neovascular age-related macular degeneration.  In April 2023, Samsung Bioepis announced 1-year outcomes of its Ph III study of SB15 at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.

Samsung Biologics and Pfizer announced that they have entered a new long-term strategic partnership for manufacturing of Pfizer’s biosimilars portfolio.  According to a Samsung Biologics company filing, the contract is worth US$411M.  Using its newest facility, Plant 4, Samsung Biologics will provide Pfizer with additional capacity for large-scale manufacturing of biosimilars covering oncology, inflammation, and immunology.

This news comes only days after Samsung Biologics announced it will accelerate the timeline for construction and operations of its new, fifth manufacturing plant.

Merck announced the US Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA®, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin chemotherapy for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).

Eisai and Biogen announced that Eisai filed a marketing authorisation application (MAA) for LEQEMBI® (lecanemab) for treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology in the brain.  The submission for the investigational anti-amyloid beta antibody was made to the Ministry of Food and Drug Safety in South Korea based on positive results from Phase III and Phase IIb studies

Eisai submitted an MAA to the MHRA in the UK for LEQEMBI® only a few weeks ago.

Samsung Biologics announced that it will accelerate the construction and completion of Plant 5, which will now be in operation by April 2025.  The plant will add 180,000L capacity to Samsung Biologics’ capabilities, so it will maintain the world’s largest biomanufacturing capacity at 784,000L upon completion.  Samsung Biologics CEO John Rim announced at BIO2023 that completion of the fifth plant was initially expected in September 2025.

This week Samsung Biologics and Pfizer announced a collaboration to manufacture biosimilars.

The US District Court for the Northern District of West Virginia has granted Regeneron’s motion for judgment dismissing Mylan’s inequitable-conduct counterclaims regarding two Eylea® (aflibercept) patents (US patent nos. 10,888,601 and 11,235,572).  Chief Judge Thomas Kleeh also dismissed Mylan’s  second motion to amend its answer, defences, and counterclaims.   The case is set down for an expedited two-week trial on 12 June 2023.

In a separate judgment, the Court also denied motions for summary judgment filed by each of Regeneron and Mylan in April.  Regeneron requested summary judgment of non-obviousness in relation to its US patent no. 11,084,865.  Mylan sought summary judgment or partial summary judgment in its favour in relation to counts 12, 17, 18, and 21 of the complaint filed by Regeneron.  In relation to both requests, Chief Judge Kleeh found that genuine disputes regarding material facts existed to the extent that summary judgment for either party would be inappropriate.

Regeneron sued Mylan in West Virginia in August 2022, alleging infringement of various patents relating to Eylea®.  On 23 May 2023, Amgen filed a motion to intervene in the proceedings.

Dr Reddy’s Laboratories announced completion of a successful phase I clinical trial of DRL_TC, its biosimilar to Genentech’s Actemra® (tocilizumab) by intravenous route.  The study demonstrated the pharmacokinetic equivalence, safety, and immunogenicity of DRL_TC compared to the reference products (US sourced Actemra® and EU sourced RoActemra®), confirming similarity in pharmacodynamic parameters and no notable differences in safety and immunogenicity.

In December 2022, Dr Reddy’s announced successful phase I trial of DRL_TC by subcutaneous route.

Rani Therapeutics announced that it has expanded its partnership with Celltrion to develop an orally administered adalimumab biosimilar RT-105, following their previous collaboration on an ustekinumab biosimilar.  The partnership allows Rani to use Celltrion’s adalimumab biosimilar drug substance (CT-P17) exclusively for the development and commercialisation of RT-105.   Celltrion will have the option to acquire worldwide rights to RT-105 after a phase I study.

Rani developed the RaniPill® capsule, an oral delivery technology which intends to replace subcutaneous or intravenous injection of biologics and drugs.  This is the first announced partnership for a program involving the RaniPill® HC, a high-capacity device in preclinical testing that delivers 20mg of payload with high bioavailability.

Samsung Biologics revealed in a regulatory filing with Korea Exchange that it has signed a US$81M CMO contract with a ‘European pharmaceutical company’.  The contract amount is 3.58% of sales and is binding on the two companies.  Samsung said that when the main contract is concluded in the future, the confirmed details will be disclosed.  The EU pharma company name must be disclosed by 1 January 2024 according to the corporate filing.

In March 2023, Samsung Biologics announced it will begin construction of its fifth plant in Korea.

Celltrion has received marketing authorization from the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) for Remsima® SC, biosimilar to Janssen’s Remicade® (infliximab). It has been approved for the full range of indications previously approved for Remicade®, namely rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, adult Crohn’s disease, and adult ulcerative colitis.This news comes as Celltrion launched Remsima® SC in Brazil on 22 May 2023, and has received approval in several other jurisdictions (EuropeKorea and Canada) for treatment of various inflammatory conditions.

Chia Tai Tianqing announced that it received a drug registration certificate from China’s National Medical Products Administration for DELITUO® biosimilar to Roche’s Mabthera® (rituximab). It is indicated for treatment of non-Hodgkin’s lymphoma (follicular lymphoma, CD20-positive diffuse large B-cell lymphoma, chronic lymphoma Tumor cell leukemia).

In March 2022, Henlius obtained NMPA approval of its rituximab biosimilar (汉利康®).

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Sian Hope

Sian Hope

Associate Lawyer

Sian is a driven intellectual property associate with a background in molecular genetics and experience in both private practice and within State Government. Sian’s experience working in medical research and advanced therapeutics policy supports Pearce IP’s clients on policy issues relating to the regulation of pharmaceutical/biopharmaceutical products in Australia.

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