Biosimilars Deals 2021 Archives

Pearce IP BioBlast™: w/e 11 December 2020

Dec 14, 2020

24 Nov 20 | Novartis released its annual report ‘Meet Novartis Management 2020‘. In the report, Novartis announced that GP2411 (biosimilar denosumab candidate) has commenced Ph III trials. Novartis also indicated it plans to launch biosimilar adalimumab (in Australia and Canada) and natalizumab in 2021-2023 and denosumab in 2024-2026.

28 Nov 20 | Shanghai Henlius Biotech reported positive results from Ph III trials of its biosimilar bevacizumab candidate.

01 Dec 20 | US | US District Court Judge Leonard Stark refused to grant costs in the Coherus/Amgen (pegfilgrastim) matter. Coherus argued that fees were warranted because Amgen had pursued a baseless claim and appeal, intending to thwart competition.

02 Dec 20 | US | Boehringer Ingelheim filed a Citizen Petition asking the Commissioner of Food and Drugs to interpret the term ‘strength’ in s 351(k) of the PHS Act for parenteral solutions to mean ‘total drug content’. The current interpretation does not allow a biological product to be licensed as a biosimilar and/or interchangeable product if there is any variation in inactive drug volume. BI has argued that the proposed interpretation may increase access to more affordable biosimilar and interchangeable biological products.

AstraZeneca to acquire Alexion

Dec 12, 2020

Biopharma supplier Alexion announces it will be acquired by AstraZeneca. The acquisition is expected to close in Q3 2021 for total consideration to Alexion shareholders of $39bn. Under the deal, AstraZeneca will acquire Alexion’s pipeline of 11 molecules, as well as Alexion’s blockbuster products Soliris® (eculizumab) and Ultomiris® (ravulizumab).

First patient dosed in Ph II trials of IBI310 and Tyvyt®

Dec 11, 2020

Innovent announces the first patient has been dosed in its Ph II trials of IBI310 (anti CTLA-4 monoclonal antibody) in combination with Tyvyt® (sintilimab) for the treatment of second-line or above advanced cervical cancer.

New study shows long-term biosimilarity of Truxima® to Rituxan®

Dec 11, 2020

A new long-term efficacy and safety study demonstrated the biosimilarity of Celltrion’s CT-P10/Truxima® (infliximab) to Rituxan® at 27 months in patients with low-tumor burden follicular lymphoma.

Alvotech and Fuji Pharma extend strategic partnership

Dec 10, 2020

Alvotech and Fuji Pharma announced they have agreed on an extension of their exclusive strategic partnership for the commercialisation of four biosimilar medicines in Japan.

Merck receives positive opinion from CHMP for pembrolizumab

Dec 10, 2020

Merck receives a positive opinion from the EU’s CHMP for an extended indication set for Keytruda® (pembrolizumab). If approved, Keytruda® will also be indicated for metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

Celltrion receives positive opinion from CHMP for Yuflyma®(biosimilar adalimumab)

Dec 10, 2020

Celltrion receives a positive opinion from the EU’s CHMP for its proposed 100mg/mL adalimumab biosimilar Yuflyma® for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis. If approved, this will be the first registered high concentration, citrate-free adalimumab biosimilar anywhere in the world.

Biologics dominate list of costliest drugs

Dec 9, 2020

On 01 December NPS Medicine Wise published its annual list of the top 10 PBS drugs by cost to the Australian government. Biologics dominated the list, taking 7 of the top 10 places, including the top 5 positions. The top product aflibercept costs the government $392 million for 315,200 prescriptions, followed by nivolumab ($345 million/51,882 prescriptions), pembrolizumab ($343 million/38,860 prescriptions), adalimumab ($321 million/257,328 prescriptions), denosumab ($244 million/884,413 prescriptions), ranibizumab ($218 million/190,126 prescriptions) and ustekinumab ($211 million/29,603 prescriptions).

All 7 of these biologics featured in the 2018-19 top 10 list, however there are marked increases in the cost of several of the products. In particular, the total prescriptions of nivolumab decreased by approximately 2000 compared to last year, but the cost of the product increased by $77 million. There are currently no biosimilars available in Australia for any of these products.

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.

Jane Halton appointed as GBMA Chair

Dec 9, 2020

The Generic and Biosimilar Medicines Association announced it has appointed Ms Jane Halton AO PSM as its inaugural Independent Chair. Halton will bring a wealth of experience to the role, as former head of the Department of Health (2002-2014), and Department of Finance (2014-2016).

Halton has also held the positions of Chair of the Board of the World Health Organisation, President of the World Health Assembly and Chair of the Organisation for Economic Co-operation and Development Health Committee. More recently, Halton was appointed as a Commissioner on the National COVID-19 Commission Advisory Board.

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.

Intas Pharma’s Romy® demonstrates high overall response rate

Dec 9, 2020

A new study indicates Intas Pharma’s romiplostim biosimilar Romy® has demonstrated a high overall response rate without adverse events in patients with immune thrombocytopenic purpura. Romy® has been approved in India.

Prof. Anurag Rathore awarded Agilent Thought Leader Award for research

Dec 8, 2020

Agilent awarded Prof. Anurag Rathore an Agilent Thought Leader Award for his contributions to the field of biopharmaceutical research and his work with advanced methods for molecular characterisation of biosimilars.

Pearce IP BioBlast™: w/e 04 December 2020

Dec 7, 2020

24 Nov 20 | Novartis released its annual report ‘Meet Novartis Management 2020‘. In the report, Novartis announced that GP2411 (biosimilar denosumab candidate) has commenced Ph III trials. Novartis also indicated it plans to launch biosimilar adalimumab (in Australia and Canada) and natalizumab in 2021-2023 and denosumab in 2024-2026.

28 Nov 20 | Shanghai Henlius Biotech reported positive results from Ph III trials of its biosimilar bevacizumab candidate.

01 Dec 20 | US | US District Court Judge Leonard Stark refused to grant costs in the Coherus/Amgen (pegfilgrastim) matter. Coherus argued that fees were warranted because Amgen had pursued a baseless claim and appeal, intending to thwart competition.

02 Dec 20 | US | Boehringer Ingelheim filed a Citizen Petition asking the Commissioner of Food and Drugs to interpret the term ‘strength’ in s 351(k) of the PHS Act for parenteral solutions to mean ‘total drug content’. The current interpretation does not allow a biological product to be licensed as a biosimilar and/or interchangeable product if there is any variation in inactive drug volume. BI has argued that the proposed interpretation may increase access to more affordable biosimilar and interchangeable biological products.

China’s NMPA approves Henlius’ adalimumab

Dec 7, 2020

Shanghai Henlius Biotech announces its adalimumab biosimilar HLX03 has been approved by China’s NMPA for rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.

Boehringer Ingelheim files Citizen Petition for interpretation

Dec 2, 2020

Boehringer Ingelheim filed a Citizen Petition asking the Commissioner of Food and Drugs to interpret the term ‘strength’ in s 351(k) of the PHS Act for parenteral solutions to mean ‘total drug content’. The current interpretation does not allow a biological product to be licensed as a biosimilar and/or interchangeable product if there is any variation in inactive drug volume. BI has argued that the proposed interpretation may increase access to more affordable biosimilar and interchangeable biological products.

Pearce IP BioBlast™: w/e 27 November 2020

Dec 1, 2020

22 Nov 20 | Innovent released results of Ph III trials of Tyvyt® (sintilimab) with Byvasda® (biosimilar bevacizumab) as first-line treatment in patients with Advanced Hepatocellular Carcinoma (HCC).

24 Nov 20 | EU | The EMA approved Pfizer’s Nyvepria® (biosimilar pegfilgrastim).

24 Nov 20 | CA | BGP Pharma received a NOC from Health Canada for Hulio® (biosimilar adalimumab).

24 Nov 20 | CN | Alvotech and Alvotech & CCHT Biopharmaceutical announced they have partnered with Yangtze River Pharmaceutical Group to form an exclusive strategic partnership for the commercialisation of eight biosimilar medicines in China. Alvotech and Alvotech & CCHT will be jointly responsible for the development, registration, and supply of biosimilars in China, while Yangtze River Pharmaceutical will exclusively commercialise them. The products will be manufactured in a new biopharmaceutical facility currently being built in Changchun, China through the Alvotech & CCHT partnership.

25 Nov 20 | EU | Bio-Thera Solutions announced it has submitted a marketing authorisation application for BAT1706 (proposed bevacizumab biosimilar) in EU.

26 Nov 20 | The Centre for Biosimilars reported on Alvotech’s global biosimilar strategy. Dr Joseph McClellan, Alvotech’s Chief Scientific Officer commented on Alvotech’s long-term expansion plans for global biosimilars markets, suggesting that Alvotech will obtain regulatory approvals for multiple products almost simultaneously in multiple countries before launching.

US District Court refuses to award costs in pegfilgrastim dispute

Dec 1, 2020

US District Court Judge Leonard Stark refuses to grant costs in the Coherus/Amgen (pegfilgrastim) matter. Coherus argued that fees were warranted because Amgen had pursued a baseless claim and appeal, intending to thwart competition.

Preliminary discovery not justified by fear of a future product launch

Dec 1, 2020

In Pfizer Ireland Pharmaceuticals v Sandoz Pty Ltd [2020] FCA 1648, the Federal Court of Australia declined to order preliminary discovery against Sandoz, the holder of an ARTG registration for biosimilar etanercept, that had no present intention to launch its ERELZI® product in Australia. The Court was unwilling to make such an order based on the hypothesis that Sandoz would threaten to infringe Pfizer’s etanercept patents in the future.

Factual background

Sandoz sought ARTG approval for its ERELZI etanercept products, which are biosimilars of Pfizer’s ENBREL®. Sandoz sought the approval irrespective of any intention to launch ERELZI in Australia, as is its usual practice. The TGA approved the products.

Sandoz also sought a recommendation from the PBAC that ERELZI be listed on the PBS and the PBAC obliged. However, to obtain PBS listing, Sandoz was also required to provide pricing information, which it did not do. Instead, Sandoz stated that it had decided not to proceed with PBS listing at that time.

Pfizer has three process patents in Australia relating to aspects of the manufacture of etanercept. Following Sandoz’s TGA approval of ERELZI, Pfizer requested that Sandoz produce to Pfizer documents concerning relevant aspects of the manufacture of the ERELZI products. Sandoz declined, but offered undertakings not to launch the products without giving Pfizer 60 days’, and later 150 days’, notice of Sandoz’s intention to do so. Pfizer rejected these undertakings.

Pfizer did not push the issue again until sometime later, and notwithstanding Sandoz’s offer of a further (confidential) undertaking, Pfizer sought preliminary discovery of documents relevant to the manufacture of ERELZI pursuant to Federal Court Rule 7.2.3.

Legal requirements

To obtain preliminary discovery under FCR 7.2.3(1), Pfizer was required to:

(a) reasonably believe that it might have the right to obtain relief against Sandoz for threatened patent infringement;
(b) have insufficient information to decide whether to seek that relief, having made reasonable enquiries; and
(c) reasonably believe that Sandoz had (or was likely to have) in its control documents directly relevant to whether Pfizer had the right to obtain relief from threatened patent infringement, where inspecting the documents would assist Pfizer in deciding whether to seek that relief.

But even if Pfizer was able to meet those requirements, under FCR 7.2.3(2), the Court had discretion as to whether to order preliminary discovery in the circumstances.

Issues in dispute

The dispute between the parties centred on whether Pfizer reasonably believed that it might have the right to obtain relief against Sandoz for threatened patent infringement (FCR 7.2.3(1)(a)), and if so, whether the Court should exercise its discretion to order preliminary discovery (FCR 7.2.3(2)).

Pfizer did not challenge Sandoz’s evidence that it had not decided whether to launch ERELZI in Australia and that, consequently, there was no proposed launch date for ERELZI, or product, in Australia. Pfizer’s position was that, in applying FCR 7.2.3, Sandoz’s intentions were subject to change and should be given little weight, and that the undertakings offered by Sandoz afforded Pfizer insufficient time in which to seek preliminary discovery to support an application for an interlocutory injunction to prevent Sandoz from launching. Pfizer also submitted that the Court could make the order for preliminary discovery but not require Sandoz to produce responsive documents until Sandoz notified Pfizer of an intention to launch. This would give Pfizer sufficient time to inspect the documents and seek an interlocutory injunction against Sandoz.

The decision

Justice Burley considered Pfizer’s application for preliminary discovery to be misconceived because FCR 7.2.3(1)(a) required Pfizer to believe that it might have the right to obtain relief from threatened patent infringement at the date the application was assessed by the Court. Pfizer did not have that belief. Rather, Pfizer’s belief was contingent on Sandoz deciding to launch ERELZI in Australia sometime in the future. In those circumstances, Pfizer was asking the Court to rule based on hypothetical facts, which it was reluctant to do. Instead, if Sandoz’s notice of its intention to launch did not give Pfizer sufficient time to seek preliminary discovery and an interlocutory injunction against Sandoz, Pfizer could approach the Court to make urgent orders to protect its position.

The Judge would have declined to order preliminary discovery under FCR 7.2.3(2) for substantially the same reasons.

Conclusions

To succeed in an application for preliminary discovery in Australia, a patentee must reasonably believe that it may have the right to obtain relief from threatened patent infringement when the application is assessed by the Court. A patentee’s belief that it may have a right to relief from threatened patent infringement at some point in the future is insufficient for the Court to order preliminary discovery.

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.

Bio-Thera submits EU MA for bevacizumab

Nov 26, 2020

Bio-Thera Solutions announced it has submitted a marketing authorisation application for BAT1706 (proposed bevacizumab biosimilar) in EU.

The Centre for Biosimilars reports on Alvotech global biosimilar strategy

Nov 26, 2020

The Centre for Biosimilars reported on Alvotech’s global biosimilar strategy. Dr Joseph McClellan, Alvotech’s Chief Scientific Officer commented on Alvotech’s long-term expansion plans for global biosimilars markets, suggesting that Alvotech will obtain regulatory approvals for multiple products almost simultaneously in multiple countries before launching.

EU approves Tremfya® (guselkumab) for the treatment of psoriatic arthritis

Nov 25, 2020

Janssen announced that the European Commission has approved Tremfya® (guselkumab) for the treatment of adult patients with active psoriatic arthritis.

Novartis provides updates on Sandoz biosimilar candidates

Nov 24, 2020

Novartis released its annual report ‘Meet Novartis Management 2020‘. In the report, Novartis announced that GP2411 (biosimilar denosumab candidate) has commenced Ph III trials. Novartis has also indicated it has planned launches for biosimilar adalimumab and natalizumab in 2021-2023 and denosumab in 2024-2026.

Alvotech and Yangtze River Pharmaceutical Group form strategic partnership

Nov 24, 2020

Alvotech and Alvotech & CCHT Biopharmaceutical announced they have partnered with Yangtze River Pharmaceutical Group to form an exclusive strategic partnership for the commercialisation of eight biosimilar medicines in China. Alvotech and Alvotech & CCHT will be jointly responsible for the development, registration, and supply of biosimilars in China, while Yangtze River Pharmaceutical will exclusively commercialise them. The products will be manufactured in a new biopharmaceutical facility currently being built in Changchun, China through the Alvotech & CCHT partnership.

Health Canada grants NOC for Hulio®

Nov 24, 2020

BGP Pharma receives a NOC from Health Canada for Hulio® (biosimilar adalimumab).

Pearce IP BioBlast™: w/e 20 November 2020

Nov 23, 2020

Significant biosimilar activities this week include

15 Nov 20 | US | Genentech filed a complaint against Centus Biotherapeutics, Fujifilm Kyowa Kirin Biologics, Fujifilm Corp and Kyowa Kirin relating to its proposed bevacizumab biosimilar. Genentech asserts that Centus failed to provide sufficient information for Genentech to complete an analysis of potential patent infringements.

17 Nov 20 | The International Generic and Biosimilar Medicines Association (IGBA) launched the first Global Biosimilars Week.

17 Nov 20 | Pulse News reported Celltrion’s Q3 2020 earnings have increased 46.4% from the same period last year. This success has been attributed to sales of its HIV drug, and strong demand for biosimilars including Remsima® (biosimilar infliximab) and Truxima® (biosimilar trastuzumab).

18 Nov 20 | Samsung Bioepis and Biogen announced the FDA has accepted for review the BLA for SB11 (proposed ranibizumab biosimilar).

18 Nov 20 | Samsung Biologics began construction of the world’s largest biopharmaceutical manufacturing facility in Incheon, South Korea. The plant is expected to commence some operations by the end of 2022, with full operations to commence in 2023.

19 Nov 20 | Alvotech announced the FDA and EMA have accepted regulatory submissions for AVT02 (proposed adalimumab biosimilar). Approval is expected in the US in September 2021 and Q4 2021 in the EU.

19 Nov 20 | Korean Biomedical Review reported Samsung Biologics and AstraZeneca to liquidate their joint venture Archigen Biotech. This JV was created for the development of a rituximab biosimilar. The project has been discontinued due to a perceived lack of commercial viability.