Fujifilm Kyowa Kirin Biologics and Mylan announced the launch of Hulio® in Japan. Hulio® is available in a 40mg/0.8mL syringe and pen presentation (indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, ankylosing spondylitis, Entero-Behcet’s Disease and Crohn’s Disease), and a 20mg/0.4mL syringe (indicated for juvenile idiopathic arthritis). This is the first adalimumab biosimilar to be launched in Japan.
Celltrion’s Yuflyma® (biosimilar adalimumab) approved in the EU
Celltrion announced it received EC marketing authorisation for Yuflyma® (biosimilar adalimumab) across all indications. This is the first approval of a high concentration, low-volume biosimilar adalimumab. The EPAR is yet to be published by EMA.
Tabuk partners with Prestige on Tuznue®(biosimilar trastuzumab)
Saudi Arabia’s Tabuk Pharmaceuticals announced it has reached an exclusive licensing and distribution agreement with Korea’s Prestige Biopharma for the commercialisation of Tuznue® (biosimilar trastuzumab). Under the agreement, Tabuk will receive exclusive rights to commercialise and distribute Tuznue® in the Middle-East and North Africa region.
EU approves Biocon Biologics/Viatris’ Kixelle®(biosimilar insulin aspart)
Biocon Biologics and Viatris announced Kixelle® (biosimilar insulin aspart) has received marking authorisation approval in the EU.
Roche releases Ph III results of follow-on faricimab
Roche announced new Ph III data shows faricimab (given at intervals of up to four months) is non-inferior compared to aflibercept (given every two months). This may reduce the treatment burden for patients suffering from diabetic macular edema and neovascular age-related macular degeneration.
Exclusive licensees: are you stuck in a “No Standing” zone?
Under Australian law, patent infringement proceedings may be started in the Australian Federal Court only by a patentee or an exclusive licensee.[1] When it comes to determining the identity of the patentee or exclusive licensee, the Court will look to the particulars as recorded in the Register of Patents (‘the Register’).[2]
Therefore, if you are an exclusive licensee, but have not taken the step of recording your exclusive license on the Register through the Australian Patent Office, the Register will not reflect that you hold those exclusive licence rights. In such a case, you may be stuck in a “No Standing” zone: without leave of the Court,[3] your licence will be inadmissible, and you will have no standing to sue.
Although it is not mandatory to record an exclusive licence on the Register, doing so before commencing litigation to enforce a patent is strongly advisable. The process of recording an exclusive licence is straightforward, requiring an electronic copy of the licence agreement to be submitted to the Australian Patent Office accompanied by a request for its recordal in the Register against one or more patents.
Recording your exclusive licence early, and before litigation is on the horizon, can allow you to move immediately against an infringer without being delayed or distracted by first having to update the Register.
[1] Patents Act 1990 (Cth) s 120(1).
[2] Ibid s 195(1).
[3] Ibid s 196(1).
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.
TGA seeks consultation on issues relating to the registration of off-label use of medicines: Part 1
TGA has invited submissions on its consultation paper released last Thursday designed to facilitate indication “repurposing”, a phrase coined by TGA to describe the Australian registration of new indications for known medicines. In particular, the TGA has sought submissions on the potential obstacles and incentives to ‘repurposing’ medicines.
The scope of the consultation extends to medicines currently or previously on the ARTG, including both generic and innovator medicines under patent/exclusivity protection, but excluding extensions of indications to closely related conditions.
TGA has proposed three options to motivate pharma/biopharma companies, industry bodies and patient groups, to seek registration of new indications:
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Option 1: Reduce the regulatory burden for repurposing medicines through measures such as fee relief, streamlined reimbursement evaluation, and exclusivity periods for new indications;
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Option 2: Support the development of repurposed drugs through enhanced access to information relating to Australian medicines usage data, to support the preparation of dossiers;
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Option 3: Pursue registration and potential PBAC review of additional indications for medicines, including through initiatives such as sponsorship of new indications of a medicine by non-commercial organisations; forcing sponsors of medicines to make an application for new indications (or risk committing an offence); and approving the inclusion of additional indications without the need for an application from the sponsor.
Each of the three options could result in significant legal, commercial and economic consequences for the AU pharmaceutical industry. TGA has allowed only 1 month for industry to consider the proposals and provide feedback. We summarise some of these potential impacts in Part 2 of this Blog which will be published on Monday 15 February.
Feedback can be provided to TGA via an online survey, or by submitting a response document. The consultation period closes on 23 March 2021.
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.
Lannett and HEC reach insulin aspart agreement
Lannett announces it has entered into an agreement with the HEC Group of companies for biosimilar insulin aspart. Under the agreement, Lannett will be responsible for funding most of the clinical development requirements, while HEC will continue to develop the product and manufacturing infrastructure.
Celltrion commences Ph III aflibercept trials
Celltrion announces it has commenced Ph III trials of its proposed aflibercept biosimilar.
Pearce IP BioBlast®: w/e 05 February 2021
29 Jan 21 | EU | The CHMP recommended 13 medicines for approval. Among the recommendations were two bevacizumab biosimilars, Mabxience’s Alymsys® and STADA’s Oyavas®.
01 Feb 21 | CA | Celltrion announced it has received a notice of compliance from Health Canada for Remsima® SC (subcutaneous infliximab). Remsima® has been approved for the treatment of rheumatoid arthritis.
01 Feb 21 | US & CA | Coherus Biosciences announced it has reached an agreement with Junshi Biosciences for the development and commercialisation of toripalimab (anti-PD-1 antibody) in the United States and Canada. Toripalimab has received breakthrough therapy designation by the FDA for nasopharyngeal carcinoma and the first BLA is expected to be filed later this year.
04 Feb 21 | IN | Enzene Biosciences announced it has received marketing authorisation for its biosimilar teriparatide in India.
04 Feb 21 | In an interview with the Centre for Biosimilars the head of Celltrion’s Medical and Marketing Division, HoUng Kim PhD, discussed its high concentration, citrate-free adalimumab biosimilar. Kim announced that Celltrion has completed patent settlements in the US and is approaching settlements in Europe. Kim also revealed that the application for Celltrion’s US biosimilar adalimumab product was filed in November 2020.
Roche reports huge erosion of YoY CER growth in key areas
Roche reports a huge erosion of its year on year CER growth in key areas, attributing this decline to COVID-19 impacts and biosimilars. Roche reported the YoY CER growth of Avastin (bevacizumab) was -25%, with the hematology franchise (including rituximab) at -22% and HER2 franchise (including trastuzumab and pertuzumab) at -8%.
Celltrion discusses its adalimumab biosimilar
In an interview with the Centre for Biosimilars the head of Celltrion’s Medical and Marketing Division, HoUng Kim PhD, discussed its high concentration, citrate-free adalimumab biosimilar. Kim announced that Celltrion has completed patent settlements in the US and is approaching settlements in Europe. Kim also revealed that the application for Celltrion’s US biosimilar adalimumab product was filed in November 2020.
Enzene Biosciences receives biosimilar teriparatide approval
Enzene Biosciences announces it has received marketing authorisation for its biosimilar teriparatide in India.
Coherus Biosciences and Junshi Biosciences reach toripalimab agreement
Coherus Biosciences announces it has reached an agreement with Junshi Biosciences for the development and commercialisation of toripalimab (anti-PD-1 antibody) in the United States and Canada. Toripalimab has received breakthrough therapy designation by the FDA for nasopharyngeal carcinoma and the first BLA is expected to be filed later this year.
Celltrion receives approval for biosimilar infliximab from Health Canada
Celltrion announces it has received a notice of compliance from Health Canada for Remsima® SC (subcutaneous infliximab). Remsima® has been approved for the treatment of rheumatoid arthritis.
Pearce IP BioBlast®: w/e 29 January 2021
25 Jan 21 | Samsung Bioepis announced the opening of its new headquarters in Incheon. The building was complete in December 2020, and will house approximately 1000 new employees, laboratory and office space.
27 Jan 21 | US | Health care performance improvement company Vizient released its Winter 2021 Pharmacy Market Outlook. Vizient projected that the greatest price increases to members would occur in Humira® (adalimumab), with a 7.5% price increase predicted over the next 18 months. Adalimumab also topped the list of greatest total spend by product among Vizient members, followed by pembrolizumab, rituximab, infliximab, ustekinumab, nivolumab and denosumab. New figures also showed trastuzumab biosimilars have captured a significant market share, contributing to 39% of cost to members in September 2020.
28 Jan 21 | US | Bio-Thera Solutions announced the FDA has accepted its BLA for BAT1706 (proposed bevacizumab biosimilar).
CHMP recommends 13 medicines for approval
The CHMP recommends13 medicines for approval. Among the recommendations were two bevacizumab biosimilars, Mabxience’s Alymsys® and STADA’s Oyavas®.
FDA accepts BLA for Bio-Thera’s biosimilar bevacizumab
Bio-Thera Solutions announces the FDA has accepted its BLA for BAT1706 (proposed bevacizumab biosimilar).
Vizient releases Pharmacy Market Outlook
Health care performance improvement company Vizient releases its Winter 2021 Pharmacy Market Outlook. Vizient projected that the greatest price increases to members would occur in Humira® (adalimumab), with a 7.5% price increase predicted over the next 18 months. Adalimumab also topped the list of greatest total spend by product among Vizient members, followed by pembrolizumab, rituximab, infliximab, ustekinumab, nivolumab and denosumab. New figures also showed trastuzumab biosimilars have captured a significant market share, contributing to 39% of cost to members in September 2020.
Samsung Bioepis opens new headquarters
Samsung Bioepis announces the opening of its new headquarters in Incheon. The building was complete in December 2020, and will house approximately 1000 new employees, laboratory and office space.
Pearce IP BioBlast®: w/e 22 January 2021
18 Jan 21 | Prestige Biopharma announced it is set for an IPO in early February 2021. The IPO is expected to be worth US $348 million, with the majority of the funds to be reinvested in R&D.
18 Jan 21 | Innovent announced it has signed a licensing agreement with PT Etana Biotechnologies for Byvasda® (biosimilar bevacizumab). Under the agreement, Etana will receive commercialisation rights in Indonesia in exchange for milestone payments and double-digit royalties on net sales.
19 Jan 21 | Pharm-Olam announced it has been selected by the US Department of Defense to lead and provide full service clinical trial support of Ph II/III clinical trials of adalimumab as a COVID-19 therapeutic.
20 Jan 21 | Targeted Oncology interviewed Mark J. Roschewski MD about the preliminary results of Ph II trials of copanlisib and rituximab as treatment of patients with untreated follicular lymphoma. Roschewski reported that all the patients responded and at least had a tumour reduction.
Results of Ph I copanlisib and rituximab trials
Targeted Oncology interviews Mark J. Roschewski MD about the preliminary results of Ph II trials of copanlisib and rituximab as treatment of patients with untreated follicular lymphoma. Roschewski reported that all the patients responded and at least had a tumour reduction.
Pearce IP BioBlast™: w/e 15 January 2021
07 Jan 21 | ADQ announced it will acquire Pharmax Pharmaceuticals, as well as investing in a minority stake in Biocon Biologics.
13 Jan 21 | Kamada announced it has entered into agreements with two undisclosed international pharmaceutical companies to commercialise three biosimilar product candidates in Israel.
15 Jan 21 | Celltrion announced it has submitted an investigational new drug application for Ph III trials of CT-P41 (proposed denosumab biosimilar).
Pharm-Olam selected for adalimumab COVID-19 trial
Pharm-Olam announces it has been selected by the US Department of Defense to lead and provide full service clinical trial support of Ph II/III clinical trials of adalimumab as a COVID-19 therapeutic.
Product specific reports based on extracts from our BioBlast® database
aflibercept | Eylea® | Regeneron
bevacizumab | Avastin® | Roche/Genentech
cetuximab | Erbitux® | BMS/Merck
darbepoetin | Aranesp® | Amgen
denosumab | Prolia®/Xgeva® | Amgen
dupilumab | Dupixent® | Sanofi-Aventis
eculizumab | Soliris® | Alexion
filgrastim (GCSF) | Neupogen® | Amgen
golimumab | Simponi® | Janssen
guselkumab | Tremfya® | Janssen
infliximab | Remicade® | Johnson & Johnson
ixekizumab | Taltz® | Eli Lilly
natalizumab | Tysabri® | Biogen/Elan
omalizumab | Xolair® | Genentech / Novartis
pegfilgrastim | Neulasta® | Amgen
pembrolizumab | Keytruda® | Merck
ranibizumab | Lucentis® | Genentech
regdanvimab | Regkirona® | Celltrion
risankizumab | Skyrizi® | AbbVie
rituximab | Rituxan®/MabThera® | Genentech/Biogen
secukinumab | Cosentyx® | Novartis
tocilizumab | Actemra® | Roche
trastuzumab | Herceptin® | Roche/Genentech
BioBlast® Editor and Contributing Author
Naomi Pearce, Chantal Savage & Faran Shahzad
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